The paper focuses on the essentials of psychoanalytic process and change and the question of how the neural correlates and mechanisms of psychodynamic psychotherapy can be investigated. The psychoanalytic approach aims at enabling the patient to “remember, repeat, and work through” concerning explicit memory. Moreover, the relationship between analyst and patient establishes a new affective configuration which enables a reconstruction of the implicit memory. If psychic change can be achieved it corresponds to neuronal transformation. Individualized neuro-imaging requires controlling and measuring of variables that must be defined. Two main methodological problems can be distinguished: the design problem addresses the issue of how to account for functionally related variables in an experimentally independent way. The translation problem raises the question of how to bridge the gaps between different levels of the concepts presupposed in individualized neuro-imaging . An overview of individualized paradigms, which have been used until now is given, including Operationalized Psychodynamic Diagnosis (OPD-2) and the Maladaptive Interpersonal Patterns Q-Start (MIPQS). The development of a new paradigm that will be used in fMRI experiments, the “Interpersonal Relationship Picture Set” (IRPS), is described. Further perspectives and limitations of this new approach concerning the design and the translation problem are discussed. The recently emerged dialog between psychoanalysis and neuroscience  and interpersonal therapy (IPT) have been studied in brain imaging more often  with the intention to reduce and resolve the distress. Often patients also aim to achieve a greater self-understanding. Others wish to be supported emotionally and personally or receive guidance and instructions from the therapist for resolving their problems.The specific aspects concerning the therapeutic process and change in psychoanalysis and psychoanalytic psychotherapy address not only symptoms and dysfunctional behaviors. Another objective is to find out what may lie behind them. This is connected to the fundamental psychoanalytic concept that conscious, so-called “manifest” symptoms, thoughts and actions of the patient imply an unconscious “latent” meaning and motivation. Within a psychoanalytic perspective, conscious symptoms, and disturbances are assumed to be the result of mechanisms of defense and formations of compromise, which deal with multiple pre-conscious or unconscious factors. Such dynamics have a strong impact on how one thinks, feels, and behaves. Pre-conscious or unconscious factors may constitute intrapsychic conflicts or dilemmas, wishes, expectations, fantasies, or structural psychic functions .Consequently, a basic psychoanalytic approach to enable a therapeutic process is to generate and foster a patient's insight into and understanding of these pre-conscious or unconscious aspects and parts of him- or herself. This is to make conscious what had been unconscious before, which is part of what Freud  wrote: “On the psychoanalysts' part, the correspondent technical approach is a special form of listening (“evenly suspended attention”), the use of clarification and interpretation and the formulation of hypotheses on how the patient functions mentally to establish links to unconscious conflicts and aspects; something the patient cannot perceive on his/her own and/or accept as being connected with his/her conscious thinking and current-day functioning. However, against the patient's free association, the building of links with unconscious aspects and gaining insight in oneself, resistances and transference come into play—which both can build the grounds for interpretations of the analyst. The psychoanalytic approach aims at enabling the patient to “remember, repeat, and work through” Freud,  what hasPsychoanalysis focuses on childhood experiences and relations with significant others . These relations had and still have an impact on a person's life. It is expressed in current relationships of the patient in the here-and-now with important persons or the analyst. Beutel  summarizFreud conceived the transference of the patient  as obstacles to the therapy process. The adapted concepts were the start of developing the second basic approach in psychoanalysis and psychoanalytic psychotherapy: the focus is on what is happening in the therapeutic relationship on the basis of transference and countertransference. Dysfunctional, maladaptive relationship patterns, fears, and wishes of the patient tend to be repeated in the relation to the analyst. The relation toward the analyst  constitutes the groundwork for the patient's internal structure of expectations in relationships. The analytic setting fosters the evolution of these inner conceptions. Within the transference situation, unconscious processes can be actualized. Experiencing a secure attachment with the analyst the patient may be enabled to become aware and reconstruct his/her memories and relationships (that may have structured him/her) and eventually work them through.Andrade  stressesThe Boston Change Process Study Group  depicts Within a psychotherapeutic environment, Sterba  describeBeutel and Huber  state inFrom a neuroscientific perspective, the problem of showing these effects within methodical borders remains a challenge for the future. For instance, Zwiebel  depicts How can the complexity of input variables be dealt with in order to enable future brain imaging studies in psychodynamic psychotherapy? The general aim of this paper is to discuss the variables that need to be controlled and measured in studying the neural effects of psychodynamic psychotherapy. We will discuss the various variables and the methodological problems which can be subsumed under two main headings, the design problem and the translation problem. The design problem addresses the issue of how to account for functionally related variables in an experimentally independent way. For instance, the activation tasks employed in brain imaging should somehow mirror and simulate those functional processes that are assumed to mediate the therapeutic effects of psychodynamic psychotherapy. Experimentally however, we need to measure and account for both variables in an independent way without any confusion between them. The translation problem raises the question of how to bridge the gaps between the different levels of the concepts presupposed in such investigation. The gap between the personal level of the therapist and the client on the one hand, and the neural level of the brain on the other, needs to be bridged. There is also a gap between the behavioral effects of psychodynamic psychotherapy the therapist can observe and the subjective effects the client himself experiences. Finally, the gap between the psychodynamic level of the psychodynamic psychotherapy, the psychological level of the activation task in brain imaging and the neural level of the parameters to be measured needs to be bridged. The development of bridges for the various gaps is crucial in developing an experimentally sound design that allows for valid and reliable measurement and interpretation of the data. We will discuss both problems here, the design problem and the translation problem in their various facets which will be illustrated by a specific example, the example of introjection (see below for exact definition).The design problem deals with the issue how to account for functionally related variables in an experimentally independent way. Relevant inputs that enter such study designs include the psychotherapist, the client, the therapeutic relationship and the investigator, i.e., the experimentator , this psychological study supports the crucial importance of empathy in psychotherapists. Certainly though further studies are necessary to reveal the exact role of empathy and its distinct aspects . Sandler et al.  also poiAnother variable the psychotherapist himself puts in are of course the psychotherapeutic interventions he uses to induce psychotherapeutic change; the factor accounting for the psychotherapeutic intervention may be conceptualized as “psychotherapeutic input” which describes the intervention the psychotherapist uses to induce therapeutic change in the client. Freud  tackles In addition to psychotherapeutic input and psychodynamic process, we also need to account for the psychotherapeutic output, the effects. There have been various studies showing the therapeutic efficacy of psychodynamic psychotherapy  a specific concept and theory of brain function. For instance, presupposing strict localizationism and modularity, he may hypothesize that neural activity in a specific region like the often observed abnormality in the subgenual anterior cingulate cortex Mayberg,  may be cAlternatively to localizationism, one may assume neuronal integration. Neuronal integration describes the coordination and adjustment of neuronal activity across multiple brain regions. The interaction between distant and remote brain areas is considered necessary for a complex function to occur, such as emotion or cognition  psychodynamic concepts and thus psychotherapeutic interventions which leaves open conceptual and empirical space for including variables other than purely neural ones.Another important empirical implication of the conceptual difference between persons and objects is the difference between individual and general levels. Persons concern individual subjects each with major idiosyncrasies both psychodynamically and neurally. The focus of psychodynamic psychotherapy is always on the individual, its specific subjective and personal contents as derived from its life history. Psychoanalysis gives us a conceptual framework to link these individual contents, as they are experienced from the inside of the experiencing person itself, to general structures of the psyche of persons, as they are observed from the outside by the observer. Neuroscience, in contrasts, concerns the brain as we can observe it from the outside; thereby however the individual person's specifics get lost because the experimental approach averages across different individual subjects. The difference between individuality and generality marks a principal difference between psychoanalysis and neuroscience which is nicely expressed by David Milrod  presupposing mere correlation and one-to-one mapping strategies. The principles of neural integration refer rather to the organization of neural activity and hence to what we call neural organization.If one now searches for psychodynamic concepts in specific neural regions and networks, one may attempt to link structures of psychological organization with neural contents. This however may be doomed to fail because one then confuses the level of organization, as presupposed on the psychological level, with the level of contents, as implied by the neural level, with both remaining unable to match or correspond on a one-to-one basis. Instead, one may rather link psychodynamic concepts to the neural organization with both presupposing and implying analogous structures. This however remains rather speculative at this point . This contrasts with neuroscience which requires third-person observation of neuronal states. Due to the neglect of first-person subjective experience, neuronal states as third-person data can be quantified and objectified. This, in contrast, remains impossible in the case of first-person data which are rather qualitative and subjective. If, however, the neuronal processes of mechanisms are to be investigated, subjective experience and neuronal states  have to be linked to each other in a systematic way. For this purpose, we have created an appropriate methodological strategy, First-Person Neuroscience, which aims at systematically linking first- and third-person data , a self-report version of the OPD-2 axis “interpersonal relations,” has been developed , which we plan to use in fMRI experiments. In the following the different steps of its development will be described.©). Each picture shows two or more black stick figures on white background. The figures vary in size, but do not show any gender specification, facial expression, clothes, or other specific characteristics. Some figures, e.g., the figure taking a neutral body position, occur repeatedly in different pictures. Different interpersonal situations are expressed only in the specific posture of figures as well as their positions toward each other.The MIPQS provides 32 items describing patterns of interpersonal behavior. The IRPS comprises pictures illustrating interpersonal behavior patterns. The pictures were developed step-by-step. At first, there had been an attempt to illustrate the interpersonal situations by means of multicolored symbols. However, this approach was abandoned because of the high level of abstraction of these symbols. Consecutively, a collection of pictures illustrating the different situations by means of stick figures was composed . The data for all variables collected were subjected to descriptive statistics according to the respective scale level. In order to assure direct interpretability of results of both tasks, the data analysis was limited to descriptive statistics. This included indicating the proportion of correct responses for multiple choice tasks in percentage and the median for nine-point Likert scales.In a further step, we tested the correspondence between the IRPS and the MIPQS when participants performed them separately. A number of patients suffering from Major Depressive Disorder (MDD) were recruited from the Department for Psychiatry, Psychotherapy, and Psychosomatics of the University Hospital of Psychiatry Zurich. Patients with neurological or other physical illnesses, disorders of personality, alcohol- or substance abuse were excluded. Diagnosis was made according to DSM IV  the six target pictures are presented. A second condition  consists of pictures rated beforehand by the participants as being not typically representative for their interpersonal behavior. The control condition  includes pictures showing a number from two to four stick figures in a frontal, neutral position  describing a central dimension in psychodynamic psychotherapy: changes in interpersonal behavior and associated feelings. We hence try to isolate a specific mechanism relevant in the psychodynamic treatment of depression and operationalize it in an fMRI experiment. The experiment incorporates a number of specific principles that are, in our view, of great importance for this type of experimental design.First, focus is set on the very individual dimension of experience as well as their emotional implications. This is reflected in the individual choice and subjective determination of meaning of stimuli (IRPS pictures) used during neuro-imaging.Second, the association of the picture to autobiographical experience should strengthen the affective reaction of the participant when the IRPS pictures are presented in the scanner. During the scanner procedure, participants rate their subjective emotional arousal induced by the IRSP pictures. Having a subjective rating of this kind enhances the validity of the experiment.Third, the use of visual stimuli in form of pictures may reduce the cognitive demand on participants during fMRI examinations compared to tasks involving stimuli using words or sentences.Fourth, the fMRI experiment comprises a valid control condition. The control condition consists in presentation of (a) IRPS pictures that the patient rated as non-relevant for himself; (b) pictures showing stick figures in a neutral position.Results of fMRI exams will be linked to results from other diagnostic instruments such as the OPD and a series of others questionnaires. By the choice of these instruments, we tempt to take into account the complexity of subjective experience.There are several factors that have been pointed out earlier to be relevant for the design of neuro-imaging paradigms in psychodynamic research that are not taken into account in our paradigm. This includes factors resumed under the “design problem” as well as those evoked concerning the “translational problem.” For example, we have not considered the psychotherapist or the therapeutic relationship as “input” in depth. Our design includes one questionnaire possibly giving a hint on the matching of therapist and patient (IIP-D) but it does not include personality or attachment style ratings for the therapist. Ideally, this should also be taken into account. To give another example, we also need to carefully consider our hypothesis concerning neural activation during fMRI exams and take into account considerations illustrated earlier with reference to “the investigator as input.”Our experimental paradigm does not aspire to satisfy all of the requirements that experimental designs in psychodynamic psychotherapy research using neuro-imaging should ideally fulfill and which were described earlier in this article. In this vast and complex research domain, the development of adequate and valid experimental designs stays a defiant methodological challenge. Our experimental paradigm represents a further step into this direction. It aspires to create an experimental design that does reflect—even though in a limited way—the complexity of subjective experience.We discussed the methodological problems in designing a brain imaging study to measure neural effects of psychodynamic psychotherapy. Two main problems, the design problem and the translation problem, were encountered. The design problem points to the many inputs including the psychotherapist himself, the client, and the investigator, which each by itself may need to be included as distinct experimental variables in the study design. The translation problem refers to the different levels involved in such project such as the personal vs. the neuronal level, the psychodynamic vs. the process level, and the First-Person level vs. the Third-Person level. Thereby the personal vs. the neuronal level is of particular interest in that it includes conceptually and empirically relevant distinctions like persons vs. brains, generality vs. individuality, and organization vs. content.Taken together, this demonstrates that brain imaging studies of the neural effects of psychodynamic psychotherapy are confronted with a rather high degree of complexity raising various conceptual, empirical, and experimental problems. The discussion of these problems shall not discourage future investigators; instead it shall provide them with some suggestions for guidance through the jungle of complexity. Though any such investigation requires multi-professional efforts and emphatic collaboration, we are sure the merits are highly rewarding. The complexity of investigating the neural effects of psychodynamic psychotherapy mirrors in an almost paradigmatic way the complexity of our brain so that neuro-psychodynamic findings entail insight and a better understanding of the general principles of neural organization and our brain's very human nature. The answer to this question is two-fold: on one hand we do think that by revealing the neural mechanisms underlying psychotherapeutic processes, we may be able to develop more specific protocols of psychotherapy in orientation to the respective neural functions associated with the respective region. For instance, taking a rather simplistic example, if the level of neural activity in the amygdala may be involved in psychotherapeutic processes and even be predictive of psychotherapeutic outcome, it may be an additional indicator that the involvement of emotions may have been crucial in psychotherapeutic success. This may be the case even if the therapy was not emotion-focused but rather oriented in psychodynamic mechanisms. Such results may then be considered as evidence for the central involvement of emotional processes in the psychodynamic processes which may then lead to further refinement and specification of psychotherapeutic protocols. This raises not only the question for the linkage between emotions and psychodynamic processes but also how we, for example, can address emotions more explicitly in relation to defense mechanisms in psychotherapy. Such orientation on neural functions may then lead to the development of neurally-based psychodynamic psychotherapy in the future and may therefore be empirically, i.e., neurally, more plausible, and compatible with respect to the brain and its mode of function than the current purely clinically- and observationally-based approaches.On the other hand, revealing the neural mechanisms underlying psychotherapeutic processes may also contribute in the reverse direction, by giving us a better understanding of the psychological, i.e., psychodynamic, mechanisms associated with certain patterns of neural activity across different region. Hence, it is not only that psychodynamic psychotherapy may benefit from brain imaging but also the other way in that the latter may also be complemented by the latter.In summary, we thus assume bilateral exchange and contribution between psychodynamic psychotherapy and brain imaging. This may ultimately, as we hope, lead to the development of diagnostic and therapeutic predictive markers with especially the latter predicting what subjects may benefit from what kind of psychotherapy in general, and the kind of focus in psychodynamic psychotherapy in particular.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The prevalence of both overweight and musculoskeletal disorders (MSD) in the construction industry is high. Many interventions in the occupational setting aim at the prevention and reduction of these health problems, but it is still unclear how these programmes should be designed. To determine the effectiveness of interventions on these health outcomes randomised controlled trials (RCTs) are needed. The aim of this study is to systematically develop a tailored intervention for prevention and reduction of overweight and MSD among construction workers and to describe the evaluation study regarding its (cost-)effectiveness.The Intervention Mapping (IM) protocol was applied to develop and implement a tailored programme aimed at the prevention and reduction of overweight and MSD. The (cost-) effectiveness of the intervention programme will be evaluated using an RCT. Furthermore, a process evaluation will be conducted. The research population will consist of blue collar workers of a large construction company in the Netherlands.The intervention programme will be aimed at improving (vigorous) physical activity levels and healthy dietary behaviour and will consist of tailored information, face-to-face and telephone counselling, training instruction (a fitness "card" to be used for exercises), and materials designed for the intervention .The intervention effect on body weight and waist circumference (primary outcome measures), as well as on lifestyle behaviour, MSD, fitness, CVD risk indicators, and work-related outcomes  (secondary outcome measures) will be assessed.The development of the VIP in construction intervention led to a health programme tailored to the needs of construction workers. This programme, if proven effective, can be directly implemented.NTR2095Netherlands Trial Register (NTR):  Of thisisorders ,7. In adisorders -14. Moreisorders . Howeverisorders .Recent data obtained from periodic health screenings among 39,400 construction workers showed that the prevalence of overweight and obesity in construction workers is higher than in the general Dutch adult population. Of all construction workers 63% is overweight and 15% is obese . It is aWorkplace health promotion has been shown to play a major role in achieving such outcomes; directly by educating the workforce and providing opportunities for physical activity, and indirectly by influencing social norms . WorkplaThe present study consists of 2 phases. In the first phase a health enhancing intervention was developed, tailored specifically to the possibilities, needs and wishes of the management and employees of the participating construction company. The second phase of this study involves the evaluation of the intervention.The "VIP in construction" intervention was systematically designed based on the Intervention Mapping (IM) protocol . IM descLiterature was reviewed and interviews, questionnaires, and focus group interviews with management, employees and other stakeholders were carried out. This provided insight into the ruling health issues, underlying risk factors , and determinants of the underlying behaviours. In addition, the reach, success and failure factors of current company health promotion activities were summarised. This needs assessment results in the formulation of programme outcomes.The target group for this intervention was specified as all blue collar workers of a construction company. From interviews with the management of the company and from information obtained from Occupational Health Services (OHS) reports it was concluded that the main health concerns for the target population are overweight and MSD. In general, in the construction industry MSD are the primary reason for long-term sickness absence and disability ,21. AlsoEspecially in professions with heavy physical demands, such as those in the construction industry, muscle fatigue or musculoskeletal discomfort may be perceived during work and may eventually result in musculoskeletal pain . SeveralLiterature was reviewed to identify which theoretical constructs best predict overweight and MSD.Energy-balance-related behaviour is an important factor to consider in the development of health interventions aiming at healthy lifestyle. Weight gain, overweight, and obesity have been associated with various specific behaviours related to diet and physical activity. Risk factors for obesity are considered to be: sedentary lifestyles , a high intake of energy-dense high-fat and low-fiber diet, consumption of sugar-sweetened soft drinks, frequent snacking, and large portion sizes ,30. ProtMSD have a multifactor origin, several work-related and non work-related risk factors contribute to their development ,31,32. AIn order to be relevant, the intervention needs to account for the lifestyle habits and preferences of the target group. Therefore, to obtain information on specific dietary and physical activity behaviour in the target group, a short questionnaire was completed by a sample of 42 construction workers. These specific behaviours were further discussed in the focus group interviews. The aims of the focus groups were: identifying the main and modifiable determinants of the lifestyle behaviours , risk factors for MSD, and the reach and participation of the current company health promoting activities. Also, input from the focus group interviews was used to determine the content and design of the intervention. A total of 8 focus group interviews with construction workers (n = 62) were carried out. The focus group interviews were held at different worksites of the company to reach workers from different professions, and participants were randomly selected to avoid getting input only from workers who are already motivated to participate in health programmes.Health beliefs and health behaviours related to diet and physical activity were discussed in focus group interviews. From the focus group interviews it could be concluded that workers have some basic knowledge of nutritional standards, but they are not aware of their personal intake levels. The methods most often listed by the construction workers to improve their energy balance were less snacking and reducing alcohol consumption. Further solutions mentioned: decreasing intake of sugar-sweetened beverages or replacing them with healthier options, increasing fruit intake, and decreasing dinner portion size. From the focus group interviews we also learned that, in general, the workers' partner mainly determines the food choice at home, and the workers preferred to get personalised information on diet, as opposed to general information.The interviewed workers indicated that they believed that their work activities provided enough physical activity. However, from periodic health screening data  it is clWorkplace physical demands, such as manual material handling (lifting heavy objects), extreme weather and workplace conditions , work pace and planning were most mentioned to be risk factors at work for developing MSD. Also behavioural risk factors were mentioned, such as not taking enough rest-breaks during work, wrong work posture, and wrong use of (ergonomic) work aids. A social/managerial factor that was considered important was poor communication between supervisors and the workers concerning problems or solutions for prevention or reduction of MSD in combination with perceived barriers for addressing those problems.Although poor physical fitness was not frequently mentioned as one of the risk factors for MSD in the focus groups, improving physical capacity was mentioned as a possible preventive measure or solution. According to the literature increasing vigorous physical activity (PA) is a preventive method that targets body weight control as well as MSD -42. StroTo design a feasible intervention programme, the reach of current company health promoting activities and the requirements and design for an intervention programme were also discussed in focus group interviews. From the interviews amongst employees it could be concluded that the current health promoting activities were not optimally reaching the workers. The most important reason indicated by the interviewees was that workers were not aware of the present prevention practices, i.e. that these were not communicated in the right way. Also those who were aware of the possibilities  were often under the impression that these measures were mainly initiated for office workers of the company. From the interviews it became clear that communicating the health promoting activities in a suitable manner for the target group should be an important objective for the intervention programme.Furthermore, workers were asked about the necessary requirements and design for an intervention programme in order to reach non-participants and motivate them to participate in prevention programmes. Workers argued that an intervention programme should focus on communicating personal health risks, since perceived health was considered to be a necessary motivator for changing behaviour. From the focus group interviews we learned that the regular company periodic health screening (PHS) was generally seen as a positive starting point for discussing lifestyle. However, during the PHS there is often not enough time to discuss the outcomes. It became clear that linking the intervention to the PHS could improve participation to worksite health promoting activities.The needs assessment indicated that the intervention should address both dietary habits and physical activity with the overall programme objective being the prevention and reduction of overweight and MSD among construction workers. In addition, to specifically target and prevent MSD by improving physical capacity, workers could be stimulated to increase their general physical activity by means of specific exercises, sports, and daily physical activities during leisure time.Based on literature and focus group input, intervention strategies to prevent or reduce MSD could focus on (1) increasing physical capacity by improving general physical activity or specific exercises and/or (2) decreasing workload. However, there was no management support for implementing strategies aimed at decreasing workload. The management indicated that other company projects have already started considering physical workload; therefore decreasing workload is not a programme objective for the VIP in construction intervention.The risk behaviours described in the needs assessment were translated into health-promoting behaviours. The health behaviours that should be targeted were then formulated in programme outcomes of the VIP in construction intervention, and are presented in Table Step 2 provides the foundation for the intervention programme by specifying who and what will change as a result of the intervention. The product of this step is a set of matrices that combines performance objectives with selected personal and external determinants to produce the target of the intervention (change objectives).The programme outcomes formulated in the needs assessment were translated into performance objectives: what do the participants have to do to accomplish these outcomes? Based on the self-regulation theory and determinants for behaviour obtained from literature and focus group interviews, performance objectives were stated for each of the programme objectives. As an example, the performance objectives for the third programme objective are illustrated in Table IM states that for health promotion intervention development, instead of searching for predictors of present behaviour, health-related behaviour (e.g. high energy intake) should be translated into a health-promoting behaviour or behaviour change (e.g. energy intake reduction) and then search for determinants of the required change. The determinants for the performance objectives in this study were based on literature review and focus group interviews and were selected on importance and changeability for the specific target group. The following personal and external determinants for physical activity were identified: skills, self-efficacy, attitudes, barriers, habits, outcome expectations, resources, awareness, risk perception, and health beliefs. For dietary behaviour, the following personal and external determinants were selected for this intervention: knowledge, awareness, risk-perception, health beliefs, habits, and social support. The conceptual model of the VIP in construction intervention is described in Figure Change objectives were created by crossing performance objectives with determinants in a matrix. An example of the matrix for performance objective 3 is given in Table After constructing the change matrices, the next step was to select appropriate theoretical methods for behaviour change and to translate these into practical strategies.For each determinant  appropriate theoretical methods were identified from literature and from guidance of Bartholomew et al. (2006) . TheoretLiterature was reviewed to identify which strategies are most frequently found as part of successful interventions aimed at increasing (vigorous) physical activity and improving dietary habits. Synergies between diet and exercise in modifying body composition have been reported ,49. FurtA review on determinants of participation in worksite health promotion programmes showed that programmes that offer a multi-component strategy and focus on multiple behaviours have a higher overall participation level . When taA strategy for increasing risk awareness could be feedback on health screening. The review of Soler et al. 2010  indicateIn this step of the IM process methods and practical strategies are translated into programme components and materials. The starting point of the intervention should be informing the employees about the company health promotion activities. Personal health coaching and information materials should be added to the current health promoting activities of the company to include all determinants of the formulated programme objectives.The intervention will take place during a 6-month period and will consist of materials and tailored information on physical activity and diet, personal health coaching (PHC), and training instruction. Both the PHC protocol and specific materials were developed to be able to connect the intervention to the PHS and tailor the intervention to the needs  and wishes of the participants. Based on the baseline measurements and questionnaires a quick scan will be applied to tailor the intervention to the participants. Tailoring variables will be health indicators (BMI and waist circumference), current lifestyle behaviour  and stage-of-change .The programme materials were made attractive and recognisable for the target group by using a standard lay-out and logo. The "VIP in Construction toolbox" will consist of tailored brochures, a calorie guide, a pedometer, a BMI card and waist circumference measuring tape, recipes and a knowledge tests, an overview of the company health promoting facilities, PEP forms, and an exercise card. The exercises will consist of strengthening and stabilization exercises for the abdominal and dorsal muscles and will be well described on an exercise card. The exercises should be performed 3 times a week. The participants will receive instruction for the use of the exercise card from the PHC. The exercises on the card should be easily fitted in daily life routines; participants should be able to perform the exercises at home, and without any use or purchase of materials which potentially enhances compliance.The coaching contacts will specifically aim at the programme outcomes as formulated in the needs assessment. The coaching contacts will consist of the following elements: 1) feedback, 2) goal setting, 3) feedback on formulated goals, 4) instructions for self-monitoring, and 5) training instruction.1) The participants will receive additional feedback on their health screening and current lifestyle behaviour.2) The PHC will support in goal setting, by helping the participants in formulating a personal motivation and action plan. These plans will contain physical activities, healthy food choices or a combination. Participants will be encouraged to target behaviour that is not at the desired level. Questions will be asked on what participants want to change, and they will be asked to formulate and write down specific goals and strategies to change the behaviour. In addition, information about the company's health promoting activities will be given and the intervention materials will be distributed and clarified.3) Feedback on formulated goals will be given during the follow-up contacts. The PHC will keep a record of the goals and plans of the participant; in the follow-up contacts these goals should be evaluated. Possible barriers should be discussed and/or new goals should be formulated.4) Participants will receive instructions for self-monitoring by using the PEP forms and materials.5) The PHC will give instructions how to use the exercise card.During the intervention, participants will be coached face-to-face in formulating their personal motivation and action plan. Follow-up contacts (feedback and motivating) will be conducted by telephone. The number and duration of contacts will vary with the outcome of the quick scan, with a minimum of 2 and a maximum of 4 contacts. The number of contacts  will be determined by a participant's stage-of-change . An overview of the contacts is given in Table The product of step 5 is a plan for accomplishing programme adoption and implementation by influencing behaviour of individuals who will make decisions about adopting and using the programme and the individuals who deliver the programme.To gain insight into facilitating factors and possible barriers regarding the adoption and implementation, management and  users of the programme were interviewed. The human recourse management was involved in the programme development from the start to ensure top-down adoption in the organisation and increase of the chance of long-term implementation. During the intervention period the process will be monitored for unforeseen difficulties and possible barriers in adoption. Also a communication plan was written for the company. The main goal of this communication plan was to inform the target group and the management about the project and to obtain support from the direct management.To decrease barriers for participation, communication to the participants will be performed in cooperation with their employers, to show company involvement and support for the programme. Furthermore, the invitation to the study will be done simultaneously with the invitation to the PHS, to adapt the programme to the regular procedures. To make participation feasible for the participants the follow-up measurements as well as the first face-to-face contact with the coach will take place at the worksite and during work hours.In the planning of the programme, the planning of regular health screening was taken into consideration. Based on de schedules of the health screening, it was decided that the recruitment for the intervention should last at least 12 months, to ensure exposure to all the companies' business units, and worker age groups.The participating occupational physicians (OP) and nurses received instructions during a kick-off meeting as well as by e-mail and telephone, as they will have an important role in linking the intervention to the PHS and motivating the workers to participate. To ensure that a standardized protocol will be used by the PHCs, all coaches received a manual describing the protocol and goals for the coaching sessions in detail. Just before the start of the intervention a training session will be held.The effectiveness of the programme will be measured by performing an RCT. Participants will be measured at baseline (T0), at 6 months (T1), and at 12 months (T2). Consenting participants will be randomised to the intervention or control group after the baseline measurement. The control group will receive care as usual and will only be contacted for the baseline and follow-up measurements. The study design and procedures have been approved by the Medical Ethics Committee of the VU University Medical Centre.The research population will consist of all blue collar workers of a construction company. This will include construction site workers as well as factory workers of the company. The recruitment of participants will be conducted through the usual communication channels of the company at a non-compulsory PHS.Sample size was based on detecting a difference in change in body weight between the intervention and the control group. In each group (intervention and control) 130 participants will be needed, based on a power of 80% and an alpha of 5%, and an expected weight loss of 1.5 kg (sd 4.3 kg) as result of the intervention. The used standard deviation was subtracted from previous work from our research group, studying construction workers . Taking Randomisation will take place at an individual level. After baseline measurements the participant will be randomly assigned to either the intervention or the control group by a computer generated list using SPSS (version 15). The randomisation will be prepared and performed by an independent researcher (i.e. the research assistant).Assessment of the study parameters will be done using a combination of questionnaires and physiological measurements. Part of the study parameters will be obtained from physical examinations and questions on outcome measures are based on questions used for the PHS survey in the construction industry. In the Netherlands, this survey is widely used and tested on validity among construction workers who participate in PHS.Together with the invitation for this company PHS, all workers will receive a brochure about the study, an informed consent form, and an additional questionnaire in order to measure those variables not included in the PHS. For each study parameter, the following paragraphs describe how it will be measured for this study.2).Body weight and height will be measured at the OHS by the occupational physician or the assistant during the PHS. Weight will be measured using a digital weight scale. Body weight and height will be measured with the participants standing without shoes and heavy outer garments. Data on body weight and height will be used to calculate Body Mass Index (BMI) , questions relate to the prevalence of regular pain or stiffness in both the upper and lower extremity regions. Additionally, using the validated Dutch Musculoskeletal Questionnaire , the preThe frequency of vigorous activities will be obtained from the PHS questionnaire and moderate physical activity will be assessed by the number of days per week moderate intensity activities are performed  for at least 30 minutes. These questions relate to international physical activity guidelines  as well As a complementary method, physical activity and sedentary behaviour will be assessed objectively using accelerometers in a random sample of 50 participants of both the intervention (n = 25) and control group (n = 25). This random sample will wear an accelerometer (Actigraph) during 7 consecutive days. The accelerometer will register the actual physical activity during and outside work hours.Alcohol consumption will be obtained from the PHS questionnaire asking participants to report their average consumption (in glasses per week). Portion size at dinner, number of beverages and slices bread, as well as consumption of energy dense snacks will be assessed using questions that were also used in the Health under Construction study . AverageThe intervention will aim at improving energy balance-related behaviour . Personal coaching and feedback will be tailored to self-efficacy and stage-of-change. Therefore, it is necessary to measure these constructs for physical activity and dietary behaviour. Based on models of behaviour and behaviour change, questions will be asked on knowledge, attitudes, self-efficacy and stage-of-change for physical activity and dietary behaviours ,47.Subjective physical functioning will be measured using the RAND-36 ,67. The 2max) is considered the gold-standard for measuring aerobic capacity, its measurement requires strict protocols and trained personnel. For this study fitness will be measured by using a non-exercise test estimation model including age, BMI, resting heart rate, and self-reported physical activity [Although maximal volume of oxygen consumption  . The SCOSickness absence data (work absenteeism) will be collected from company records. Presenteeism (reduced productivity while at work) will be measured using the WHO Work Performance Questionnaire (WHO-HPQ) ,73 and tFor companies work ability is an indicator of the productivity of its own human resources. Work ability will be assessed by the Work Ability Index as measured in the PHS questionnaire.Vitality will be assessed by the six items of the Utrecht Engagement Scale (UWES) that refer to high levels of energy and resilience, the willingness to invest effort, not being easily fatigued, and persistence in the face of difficulties . In addiSince the intervention aims to increase the use of company health promoting facilities (e.g. company sponsored fitness), the use of these facilities will be reported by the participants at 6 and 12 months.These include the costs for the "VIP in Construction toolbox" and the PHC. PHC costs include costs for the health coach, housing costs, costs for printed materials, and travel expenses of the PHC. Since the PHC contacts will take place during work hours, the costs of lost productivity due to the intervention will be included as well. Coaches will record the frequency and duration of the face-to-face and telephone contacts. Intervention costs will be valued using a bottom-up approach.The use of company facilities will be valued using invoices of contractors.These include care by the general practitioner, allied health care, medical specialist, complementary and alternative medicine, hospitalisation, and medications. Data on resource use will be collected at a three monthly basis using retrospective questionnaires. Dutch standard costs will be used to value health care utilization . If thesWorkplace productivity losses (i.e. work absenteeism and presenteeism) will be valued using salaries of the participants when using the employer's perspective and using average salaries per gender and five-year age group when using the societal perspective.Since the intervention stimulates participants to engage in regular physical activity, self-reported costs related to sports activities (membership fees and sports equipment costs) will be collected on a three monthly basis.The effectiveness of the lifestyle intervention will be assessed using a regression analysis with the outcome measures at follow-up (6 months and 12 months) as the dependent variables and adjusting for the baseline levels of the outcome measure. Both crude and adjusted analyses will be performed. Linear and logistic  regression analyses will be performed using SPSS 18.0 . According to the intention-to-treat principle, all available data of the participants will be used for data analysis. For all analyses, a two-tailed significance level of < 0.05 will be considered statistically significant.A process evaluation with the aid of the RE-AIM framework will be performed to evaluate the diverse intervention components . The RE-The economic evaluation aims to determine the cost-effectiveness of the intervention compared with usual care from the societal and employer's perspective. Also, the cost-benefit will be determined from the employer's perspective. The time horizon will be one year, similar to the trial. Analyses will be performed according to the intention-to-treat principle. In the main analysis, missing data will be imputed using multiple imputation techniques . SensitiFirst, the total societal and employer's costs will be estimated, and compared between the intervention and control group. The 95% confidence intervals will be estimated using approximate bootstrap confidence (ABC) intervals . SocietaThe aim of this design article was to describe the development and plan for the evaluation of a (lifestyle) programme aimed at prevention and reduction of overweight and MSD among construction workers. This study may be of importance at company level to gain more insight in the effects of preventive measures, and to support decision making on which health promoting activities should be applied. Because the intervention is conducted in the occupational setting a large number of people can be reached, which may have an impact on health outcomes, and company as well as health care costs.The intervention was designed following the IM protocol. This has been done before in health promotion interventions -85. The Although the components of the intervention will not be evaluated separately, the process evaluation will give qualitative insight into the success factors, applicability and usefulness of the separate intervention components. Furthermore, the process evaluation outcomes can improve the programme before it will be really implemented.Creating matrices in step 5 of the intervention mapping protocol was not fully applied, as this is a very time-consuming process. However, since the most important stakeholders were involved during the design of the study, it is expected that the adoption and implementation of the programme is ensured.Health promotion efforts, particularly those directed to somewhat resistant workers who are at high risk, should preferably be integrated with the provision of improved working conditions. A systematic review of the effectiveness of health promotion interventions in the workplace concluded that participation in workplace health promotion may be increased if interventions also take into account health risks arising from work activities . In thisFinally, this programme has been developed within a specific organisation. In this study, only stakeholders from the participating company and its OHSs were involved in the feasibility assessment and the focus group interviews. Also, a specific characteristic of the construction industry is that most employees are not working at a set location. The optimal infrastructure to reach workers is possibly different in other companies/branches. Therefore, it is possible that the IM process would have led to a different protocol in other workplace settings. This should be taken into account when implementing the intervention outside the construction industry. When generalising this programme to another context, the IM procedure can be applied to modify the existing programme.In conclusion, the development of the VIP in construction intervention resulted in a health programme tailored to the needs of construction workers. The method of IM provided the tools to do this systematically. If proven (cost-)effective the programme can be directly implemented, and with minor adaptations in other companies involving blue collar workers or companies that are already offering regular health screening. OHSs or human resource managers may incorporate this method in their usual prevention management. The results of the (process) evaluation will help policy makers decide which elements of the intervention can best be used.The (cost-)effectiveness and the (implementation) process regarding this intervention will be evaluated. The results of this RCT will be available in 2012.BMI: Body Mass Index; CBA: Cost-benefit Analysis; CEA: Cost-effectiveness Analysis; CVD: Cardiovascular Disease risk; HPQ: World Health Organisation -Health and Work Performance Questionnaire; IM: Intervention Mapping; MSD: Musculoskeletal Disorders; OHS: Occupational Health Services; OP: Occupational Physician; PA: Physical Activity; PAPM: Precaution Adoption Process Model; PHC: Personal Health Coach; PHS: Periodic Health Screening; RCT: Randomized Controlled Trial; SCORE: Systematic Coronary Risk Evaluation; SQUASH: Short Questionnaire to Assess Health Enhancing Physical Activity; TPB: Theory of Planned Behaviour; VIP: Vitality in Practice; WC: Waist Circumference.The authors declare that they have no competing interests.EV and KP were involved in developing the concept and the design of the study. LV and EV were involved in further developing the idea and the protocol for carrying out the study. LV was responsible for the data collection and she drafted the manuscript. All authors contributed to the final manuscript by reading and correcting draft versions. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/12/89/prepub


Smoking cessation is necessary to reach a higher quality of life, and, for a cancer patient, it represents an important step in improving the outcome of both prognosis and therapy. Being a cancer patient addicted to nicotine may be a critical situation. We conducted a survey to monitor how many comprehensive cancer centres in Italy have an outpatient smoker clinic and which kinds of resources are available. We also inquired about inpatient services offering psychological and pharmacological support for smoking cessation, reduction, or care of acute nicotine withdrawal symptoms. What we have witnessed is a significant gap between guidelines and services. Oncologists and cancer nurses are overscheduled, with insufficient time to engage in discussion on a problem that they do not consider directly related to cancer treatment. Furthermore, smoking habits and limited training in tobacco dependence and treatment act as an important barrier and lead to the undervaluation of smokers' needs. In the last few years, Italy has made political progress in the field of tobacco control, such as the 2005 law ensuring smoke-free workplaces and hospitality venues. However, 11.1 million (21.7%) adults in Italy are still current smokers .Whereas the law is being respected in almost all bars and restaurants, irony wants it that many hospitals are still lagging behind in its implementation. We surveyed the major general hospitals in Milan, the heart of Lombardy's Health System and one of the most developed regions in Italy. Not one of the eight Milan General Hospitals made the NRT (nicotine replacement therapy) available to clinicians to deal with smoking cessation or acute nicotine withdrawal syndrome developed during the inhospital stay. In October 2008, we attended a national Health Promoting Hospitals' Conference, and were impressed by what was stated on the situation of tobacco control in three of the eight Milan General Hospitals. In the first hospital, “the No-Smoking Ban is frequently eluded not only in places like coffee break areas, bathrooms, locker rooms, offices, but also in places frequented by patients like examination rooms, the infirmary and recovery rooms.” This study was signed by the Medical and Surveillance Services and by the Quality Control Service. In the second hospital, the study conducted by the Pneumology Rehabilitation Services showed that 45% of nonsmoker employees are exposed to second-hand smoke during working hours. In the third general hospital, another study signed by the Pneumology Medical Board indicated that non-smokers exposed to second-hand smoke in hospitals accounted for 83% for men and 88.4% for women .The cancer “setting” might be a good chance to implement the smoking cessation guidelines, considering that 23.9% of all cancer deaths (33.4% men and 9.6% women) is due to smoking habits .Among hospitalized cancer patients, smokers constitute about 24.5% of the total figure and former smokers about 48.2% .Smoking cessation is an important part of cancer treatment. Different studies indicate that the smoking habit influences the outcome of surgical intervention , chemothSmoking cessation is also part of the treatment in the following conditions: lung cancer , breast Evidence-based treatments of smoking habit in oncological patients include nicotine replacement therapies, bupropion, varenicline, and behavioural counselling provided individually, in groups, or by telephone –29. HoweIn the year 2000, at the National Cancer Institute of Milan, we initiated a smoke-free campaign addressed to patients, visitors, and health personnel. The Institute became a member of the network of smoke-free hospitals, and, since 2003, an antismoking centre has been operating with an average of 350 smokers treated each year. We are at present providing pharmacological and psychological support as an inpatient service to take care of hospitalized smokers. Our pharmacy offers nicotine replacement therapy (NRT), bupropion, and varenicline for smoking cessation and treatment of inpatients' severe acute nicotine withdrawal syndrome. We have summarized, in However, our services are merely a drop in the ocean: Italy has 11 million smokers, and a considerable part of the population  lives with a prior cancer diagnosis .We carried out a telephone survey to study the Italian offer of treatment against tobacco use and dependence in 17 cancer centres (CC) belonging to “Alleanza contro il Cancro” . We focussed our survey on the services provided to smoker outpatients  and on the services provided for inpatients with lung or head and neck cancer. Our first step was to make a telephonic enquiry at the different Institution desks, asking for an outpatient antismoking clinic, and we then contacted the clinic personnel.In order to favour the cessation or reduction of smoking, six of these clinics offer both psychological and pharmacological support while one only offers group therapy. In Tables For the second part of the survey, we contacted the head nurses of the 12 lung cancer wards and of the 11 head and neck cancer wards. NRT, bupropion, and varenicline are available for inpatients in only one cancer clinic . Among tWe observed the same situation in the existing eleven head and neck cancer wards. Only one ward provides an inpatient tobacco-use treatment service and a comprehensive acute nicotine withdrawal syndrome care. The second ward, listed in the table, treats the syndrome with NRT drugs bought by relatives outside the hospital .Being a cancer patient addicted to nicotine may be a critical situation. Oncologists and cancer nurses are overscheduled, with insufficient time to engage in discussion on a problem that they do not consider directly related to cancer treatment. Health personnel's smoking habits  and limiWhat must be recognized is that this kind of care can be a great opportunity, not only to support, but to empower smoker cancer patients and to motivate profound changes in their lifestyle. In the cases of acute nicotine withdrawal symptoms, assistance can be of great comfort and help and can further improve relations between patient and hospital operators. It also works towards permanent results in smoking cessation and increases compliance with hospital no-smoking policies , 32. It is of crucial importance that oncologists of every comprehensive cancer centre offer patients, and the whole community, a service of smoking cessation; this service should be connected with the national quit line and with the antismoking centres network. They should also advocate for tobacco-free environments in their patients' communities and share, with their colleagues, their experience in dealing with the tobacco epidemic .The basic needs of smoker cancer patients affect human rights, and recognizing this is an essential part in creating a quality approach to cancer care.With a nonjudgmental and relationship-centred approach, the aim of the intervention should be to inform and support smoker cancer patients to identify and reach their own health goals according to their own needs and resources.The authors declare that there is no conflicts of interest.


Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations.This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up.This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group.ISRCTN58561170 Domestic violence and abuse (DVA) is threatening behavior, violence or abuse , characterized by coercive control, perpetrated by adults who are or have been intimate partners or family members. DVA is common; the 2009/10 British Crime Survey . The cosOver and above damage to physical health ,6 and reThere is limited evidence for the effectiveness of psychological interventions for victims of DVA. Access to psychological support within the National Health Service (NHS) in the United Kingdom is often difficult , and staA novel psychological intervention specifically tailored for women experiencing DVA, Psychological Advocacy Towards Healing (PATH), has been developed by Agnew-Davies and colleagues . The PAThttp://www.womensaid.org.uk/). Advocates engage with individual clients who are being or have been abused, aiming to empower them and linking them with community services. The core activities of advocacy are provision of legal, housing and financial advice; facilitating access to and use of community resources such as refuges or shelters, emergency housing; provision of safety planning advice; and provision of ongoing support. The duration and intensity of advocacy varies within and between agencies. Generally, advocates do not have a background or training in psychological therapies and do not provide counseling or other therapies. Although advocacy may reduce recurrence of violence, its effect on mental health and quality of life is uncertain [Women with a recent history of DVA have mental health needs that are not being met in primary care or mental health services. The United Kingdom has a network of DVA advocacy and support services, most of which are affiliated with the Women’s Aid Federation  have a psychotic illness, (2) have a severe drug or alcohol problem, (3) are unable to read English or (4) are currently attending counseling, CBT or other psychological treatments in either primary care or specialist psychiatric services.http://www.nextlinkhousing.co.uk/) and Cardiff Women’s Aid (http://www.cardiffwomensaid.org.uk/). All women who present to the DVA agencies are assessed for eligibility and invited to consider participation as part of the service’s routine intake procedures. Women who are potentially interested in participating are then referred to a female researcher who meets with them face-to-face at a safe and convenient location.Recruitment is taking place at two sites: Bristol Next Link . Randomization is stratified by whether women receive support from the safe house team or from the resettlement team at Next Link and the refuge team or tenant support team at Cardiff Women’s Aid. The randomization program applies stratification with random blocking. Within each stratum, participants are assigned to the treatment group (T) or control group (C) in randomly chosen blocks of two, four or six. Within each block, the order of assignment is also random, so that in a group of four, for example, the permutation TCTC would be equally as likely as TTCC. For each completed block, the allocation ratio is 1:1, so that the number of Ts and Cs will be equal. Allocation is concealed from the researcher until the moment of randomization.All women referred to the study are provided with a written patient information sheet and have the opportunity to discuss the study with the researcher. Informed consent is obtained from each participant in writing. After the woman consents to participate in the study, the researcher works with her to develop an individualized schedule which includes safety information and the details of friends, family or associates (locators) who will be able to help the researcher to contact the woman if contact is lost. The participant is then asked to complete a baseline questionnaire. On completion, the researcher randomizes the participant by using a remote, independent, automated telephone randomization service provided by the Bristol Randomized Trials Collaboration  for the return of questionnaire until week 12 after posting. The researcher will call the woman by telephone and, if no answer is received, leave a voice message (unless it has been explicitly stated that it is not safe to do so). After two failed telephone contact attempts, the researcher will send a text message to the woman’s last known mobile telephone number. If there is still no response, the researcher sends a handwritten card to the woman’s last known address. Failure to return a questionnaire by week 12 (after it was sent or delivered) results in the questionnaire’s being noted as missing. Researchers will continue to issue the next questionnaire in the series even if the previous questionnaire was not returned.Women randomized to receive psychological support in addition to usual DVA agency support will be assigned a specialist psychological advocate (SPA) who has gone through a 25-day manualized training program from a clinical psychologist with expertise in DVA (RAD). The training addresses the psychological impacts of DVA on women and develops therapeutic skills specifically tailored for this client group. SPAs are trained to work with women with common presenting problems within a single-session model  using a Once assigned a SPA, the participant will attend eight SPA sessions, meeting either weekly or fortnightly during the course of 2 to 3 months, with a further two booster sessions, 1 and then 3 months later. During SPA sessions, the advocates will provide time-limited interventions using a variety of primarily CBT psychological techniques, focusing within any one session on a specific presenting problem, such as hyperarousal, sleeping difficulties or parenting problems. The advocate will aim to empower the client to apply therapeutic strategies  to promote recovery from each problem. Each series of eight sessions varies according to the client’s presenting problems, but typically includes discussions about the impact of domestic abuse on mental health and common reactions, typically including posttraumatic stress and low self-esteem. The client selects a specific topic for each session, and the SPA will use written resources to guide identification of signs (symptoms), the association with experiences of abuse and strategies to overcome them within that session, and through homework tasks to be completed between sessions. Each of the eight sessions can have different content for any therapeutic dyad, although SPAs will focus on building the alliance and safety in the first session and address endings and closure in the eighth session. The follow-up sessions 1 and 3 months after the eighth session are focused on consolidating gains.In addition, the woman will receive the usual support or advocacy provided by the DVA agencies. This support can involve assistance with a variety of health and social issues, including housing problems, budgeting and debt, and legal proceedings. There is evidence that advocacy on its own can reduce physical abuse and possibly improve quality-of-life outcomes for women who have experienced DVA. Importantly, usual advocacy also provides a space for women to share their experiences and talk about their feelings in a safe and nonjudgmental environment.Control participants will have access to the usual DVA agency support and advocacy as described above. They will not receive SPA sessions, and their support worker advocate will not have received specialist training in psychological methods. The length of time a woman can be engaged with a DVA agency varies, depending on their needs and the service’s policies. Support can range from a one-off session with onward referral to regular meetings over a period of months.We are not using an attention control group, as this trial is designed (and funded) explicitly as a pragmatic (effectiveness), not explanatory (efficacy), trial, building on previous trial evidence for the effectiveness of psychological and advocacy interventions. Therefore, it is legitimate to have a treatment-as-usual rather than an attention control group. We will collect data on contact time between advocates and participants in both arms and will use that in our interpretation of the findings.This study has two primary outcomes, both collected at 1 yr after randomization. The first is the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) score . CORE-OMet al. [Some further validated mental health measures are being used: the Generalized Anxiety Disorder 7 scale (GAD-7) , the Poset al. , the Comet al. , the Shoet al.  and the et al. . All secFor the economic evaluation, data will be collected on the women’s use of health, social and criminal justice services. We will also collect data on expenses incurred by the women for attending appointments, such as travel and child-care costs. Resource use by children of participants will also be measured, such as appointments with youth offender teams and school attendance, as many of the effects of DVA on children and young people manifest as psychological, social, educational and/or behavioral difficulties -35. ThesOther variables collected in the participant questionnaires are age, number of children at home, ethnicity, income, occupation and relationship to perpetrator. The following process data are recorded by the domestic violence advocates working with the participant: number of DVA agency sessions the participant attends; the main focus of each session; and advocates’ contact time with participants, number of women entering the DVA service who do not meet the eligibility criteria or who are not interested in participating. We will also collect data on adverse events self-reported by the participant  or elicited by the DVA advocate following contact with her.Using pilot data, the sample size is based on being able to detect a difference of 0.5 in the CORE-OM score, a “reliable change index” . This wiet al. [An effect size of 0.4 to 0.5 is consistent with effect sizes detected in studies of psychological interventions using the CORE-OM as an outcome measure  and is set al.  reportedet al.  reportedA sample of approximately 30 women across both trial groups from both recruiting sites will be invited to take part in a series of three interviews spaced across their year of participation. The aim of these interviews will be to explore women’s assessment of their mental well-being and quality of life in their own words, as well as the overall acceptability and perceived effectiveness of the services they received. Topic guides include questions that explore which of the therapeutic strategies  were most useful to the women and why. Interviews are face-to-face and will last up to one hour. With participants’ consent, interviews will be recorded and transcribed verbatim. Purposive sampling based on data collected in the baseline questionnaires will ensure a diverse group of informants in terms of age, currency of abuse, and mental health status.Trial outcomes will be analyzed and reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. Baseline demographic data such as gender, age, duration of abuse and relationship to perpetrator will be summarized and descriptive summary statistics will be provided to check for imbalances between the two trial groups. For variables with continuous measures, we will report the mean and standard deviation, and for categorical data, we will report frequencies and percentages.Because the allocation will be stratified by site (Bristol vs Cardiff) and type of setting where the treatment is administered (safe house vs within community), the comparative analyses will adjust for these two factors. These will involve normal and logistic regression analyses for continuous and binary outcomes, respectively, and also, where appropriate, will adjust for the baseline scores of the outcome variables. The primary comparative analysis will compare continuous CORE-OM scores between the two groups as randomized using an intention-to-treat regression model. Secondary analysis will adjust for any factors exhibiting substantial baseline imbalance; further secondary analyses will include prespecified subgroup analyses according to the two stratification variables and age, which will be investigated by introducing the relevant interaction with treatment group into the regression model . It is pThe impact of, and reasons for, missing data will be investigated in sensitivity analyses based on multiple imputation by chained equation models (mice) -49. The We will calculate complier-average causal effect (CACE) using instrumental variables techniques to establish a stronger causal link between assignment to treatment and impact in the absence of full adherence to the treatment ,52,53. IAlthough there is literature on the economic impact of DVA, to date there has been little economic analysis of interventions aimed at improving outcomes for domestic violence survivors . The aimWe will report the direct costs of the intervention. Because the training curriculum was developed prior to the intervention ,21, starUse of NHS and PSS resources will be captured through the questionnaire. These will include primary and community health services, prescribed medication and use of hospital services. Unit costs for the valuation of these resources will be derived using the method described by Curtis , DepartmWe will present results using a cost consequences framework comparing cost from each perspective with primary and secondary outcomes . We willThe aims of the qualitative analysis will be twofold: first to understand the meaning and perceived effectiveness of the intervention in the context of the women’s lives, and second to deepen our understanding of the process of identity change for women as they move through some or all of the stages from victim to survivor to thriver . The firThis study is the first randomized controlled trial of an intervention to improve the psychological well-being of women experiencing DVA in a UK setting. The study is a collaboration with third-sector agencies that already provide a valuable service for this client group through provision of specialist support and advocacy. If a psychological program delivered by DVA advocates improves mental health outcomes for women who have experienced DVA, and if this is a cost-effective intervention, the PATH model will be appropriate for commissioning by the NHS.http://www.provide.ac.uk/).The University of Bristol is the sponsor for this trial. The study is funded through the UK National Institute for Health Research as part of the PROVIDE (Programme of Research On Violence In Diverse domestic Environments) Programme Grant for Applied Research. The Centre for Academic Primary Care at the University of Bristol is coordinating the study and monitoring and verifying the data and will analyze the results. A trial steering committee consisting of an independent chair and two other independent members, along with the lead investigator and other study investigators, will oversee the conduct of the trial. An independent Data Monitoring and Ethics Committee chaired by Harriet MacMillan, a domestic violence trialist, and comprising a statistician, trial methodology specialist and the research and policy officer for England Women’s Aid has been set up to review safety and outcome data. Further details about the trial are available at the PROVIDE website (The study has been approved by the South West Southmead National Research Ethics Service, and site-specific approvals have been received from the appropriate local research ethics committees. The study is being conducted in accordance with the ethical principles in the Declaration of Helsinki and good practice guidelines on the proper conduct of research.RAD is director of Domestic Violence Training Ltd, a private limited company which includes an aspect of training and consultancy that may potentially benefit from increased business if the trial has a positive outcome. MF is director of Cardiff Women’s Aid, and CM is director of Bristol Next Link; both organizations may benefit from commissioning of the PATH program if the trial has a positive outcome. The other authors declare that they have no competing interests.GB managed the research associates, developed standard operating procedures, secured ethics and governance approval, facilitated the trial steering committee and the data management and ethics committee, coordinated adverse event reporting and wrote the first draft of this paper. RAD developed the PATH intervention, contributed to choice of outcome measures and supervised the specialist psychological advocates. JB manages the research associates after the first year of the study, develops further standard operating procedures, facilitates the trial steering committee and the data management and ethics committee and coordinates adverse event reporting. ME conducts the qualitative study. MF manages the specialist psychological advocates at the Cardiff site. GF performed power calculations and drafted the analysis sections of the manuscript. SH designed the economic data collection and analysis. LH contributed to the design of the trial. EH recruits and follows up participants and liaises with Cardiff Women’s Aid. AM designed the qualitative study. CM manages the specialist psychological advocates at the Bristol site. TJP designed the trial and supervises the statistical analysis. FS and LS recruited and followed up participants and liaised with Bristol Next Link. DS contributed to the design of the trial. GSF designed the trial and leads the research team. All the authors contributed to the drafting and review of this paper.


Liver transplantation is a life-saving intervention for many patients with end-stage liver disease. In the past, evaluation of successful liver transplantation was based on patients’ survival rate. However, in recent years this evaluation has been based on patients’ quality of life. Various instruments have been developed to evaluate patients’ quality of life. Nonetheless, scholars still believe that it is crucial to develop a standardized and disease specific instrument for evaluating the quality of life in liver transplant recipients.The aim of this paper was to describe the development and psychometric testing process of a quality of life instrument specific to liver transplant recipients.Initial items of this instrument were extracted from a conventional content analysis study, and then were completed with findings of related international literature. The face validity was assessed by interviewing with four liver transplant recipients, and the content validity was evaluated by eleven experts in the field of transplantation. The construct validity was achieved by involving 250 liver transplant recipients through exploratory factor analysis method, and reliability was calculated by Cronbach's alpha.Three main factors with 40 items were extracted from the exploratory factor analysis: Health Satisfaction, Concerns, and Complications. Reliability of the instrument was confirmed .Given the special considerations regarding liver transplant recipients, this questionnaire is more accurate in evaluating the success of liver transplantation. Liver transplantation is a life-saving intervention for many patients with end-stage liver disease. In the past, evaluating the outcome of liver transplants was based on patients’ survival rate. Statistical information shows that the survival rate of liver transplant recipients has significantly grown in the past two decades due to developments in the treatment and care, so that now the survival rate in the first and the fifth years after transplantation are 90% and 70% respectively , 2.With recent improvements in patients’ survival rate and graft as the primary indicators of successful liver transplants, health care professionals have been paying more attention to other indicators of a successful liver transplant such as recurrence of underlying disease, transplant’s complications, and recipients’ quality of life ; in factMany studies have been intended to use quality of life in liver transplant recipients. For this reason, they tried to employ different instruments to measure this construct. Jay and his colleagues conducted a systematic review to evaluate the currently available quality of life instruments used in liver transplants recipients. This study critically appraised the psychometric properties of those instruments and their ability to consider specific concerns of liver transplant population. The authors concluded that none of the current instruments have considered certain key issues of transplant recipients, such as postsurgical complications , anxiety associated with the fear of an unsuccessful transplant, risk of malignancy and opportunistic infections, long term drug side effects, relapse and recurrence of the underlying disease, diabetes and kidney failure. The authors believe that the development of a standard and specific instrument is necessary to understand the factors affecting the quality of life in liver transplant recipients .Liver transplant has been performed in Iran since 1993. Until 2000, only forty liver transplants had been performed. This number rose to 400 cases between 2000 and 2007, and now more than 1600 liver transplants have been reported. According to the latest studies, the survival rate of recipients in the first and sixth years after transplantation were 84% and 82% respectively  offered by Waltz and Baussel . For thiAt this stage to ensure the accountability and comprehensibility of the questions, individual interviews were conducted with three liver transplant recipients.To ensure the construct validity, exploratory factor analysis was used. Principal Component Analysis and Varimax Rotation Method were used to extract the factors. At first, the questionnaire was completed by 250 liver transplant recipients . ConveniA receptionist at the transplant clinic, who was familiar with the clinical status and patients, was in charge of completing the questionnaires and addressing participants’ potential concerns. In case the patient was illiterate, the receptionist or someone close to the patient completed the questionnaire. Data collection in this phase lasted one year, from September 2011 to September 2012.At this stage, 22 respondents were asked to fill out the developing questionnaire as well as an Iranian version of sf-36 quality of life questionnaire .Internal consistency of items was achieved by using Cronbach's Alpha. We used SPSS software (version 13th), Pearson correlation test, exploratory factor analysis and Cronbach's alpha for the analysis.This research was approved and authorized by the ethics committee of Research Centre at Tehran University of Medical Sciences.Through the item generation phase, the initial questionnaire structured with 59 items was formed. In face validity stage, some items were revised and adjusted based on participant’s comments to improve their clarity and comprehensibility. For example, the item of "lack of involvement in deciding the treatment plan" was replaced with the item of “not involving the patients in their treatment plan". During the evaluation of content validity, from initial version of questionnaire nine items with CVI scores of less than 0.70 were omitted  and two items (28 and 29) were merged together due to their conceptual similarities. Therefore, the number of items was reduced to 49 . Then, tIn the next step, prepared questionnaire was changed to a Likert scale format, and was given to 250 liver transplant recipients. A total of 250 liver transplant recipients completed the questionnaire. The mean age of participants was 37 years with an average of 3 years post-transplant; 63% of the samples were men. 70% of the participants were married. Most of the subjects (40%) had a high school diploma or above, and approximately 44% of them were employed. Most patients had either hepatitis B or cirrhosis before transplantation. The results are shown in After the descriptive analysis of the data, the appraising of the appropriateness of data for factor analysis was considered. In this way, two main tests including Kaiser-Meyer-Olkin (KMO) Measure of Sampling Adequacy  and BartThe results of the analysis were as follows: First, exploratory factor analysis was conducted with a minimum load factor and regardless of the number of factors, 14 factors were extracted at this stage. Since the scree plot showed three or four main factors, further analysis was performed with three and then with four factors. At the end, three-factor analysis seemed to be more practical. These three factors with a cumulative variance of more than 40% covered most of the total observed variance . The choThese items were placed in three parts based on identified factors. All of them were evaluated based on a four-point Likert scale, in a way that in every part, 1 shows the least desirable response, and 4 the most desirable one. For example, in the first part that assesses  “health satisfaction”, number 1 is “very dissatisfied”, number 2 “fairly dissatisfied”, number 3 “fairly satisfied”, and 4 “very satisfied”. The total score of this questionnaire can be a minimum of 40 to a maximum of 160. The average time to complete this paper-and-pencil questionnaire was approximately 15 minutes.The final questionnaire consisted of 40 items, and three factors of health satisfaction, concerns and complications. The first factor is health satisfaction which covers most items and defines health according to the World Health Organization definition. This factor covers all aspects of health including physical, mental, spiritual, and social. Considering that the ultimate goal of liver transplantation is returning the patient to active life, satisfaction with all aspects of this factor is necessary. The second factor is concerns. This factor is related to concerns of liver transplant recipients in various areas, particularly follow-up issues and costs. These concerns upset the transplant recipients and influence their life satisfaction level after the transplantation. The third factor that is called complications includes physical problems and possible complications after liver transplantation. Although some of these complications are observed in other solid organ transplant recipients, some of these such as bile duct problems, and recurrence of the underlying disease are specific to liver transplant recipients. Occurrence of these complications has negative impacts on patients’ quality of life. Perhaps the only questionnaire developed for liver transplant recipients is Ferrans and Power. This questionnaire has two parts (satisfaction and importance) with a total of 70 questions which measures quality of life. It evaluates different aspects such as health and activities, psychological and emotional, social/economic, and family relationships. In this questionnaire most items are common among all versions, and in each version a few items are included to suite a particular disease. In the liver transplantation version, there are two specific items related to liver transplantation. These items evaluate the satisfaction and importance of having a liver transplant. Nonetheless, qualitative studies that assessed quality of life in liver transplant recipients, have reported several factors affecting patients’ life. Fear of transplant rejection was addressed as one of the issues which affects the quality of life in the case studies , 20. NeeThe purpose of this study was to design a valid and reliable instrument for evaluating quality of life in liver transplant recipients. Evidence shows that the available instruments measuring this concept are somewhat lack practicality. Therefore, we tried to design a tool to address the issues and needs ignored in previous questionnaires. A method combining inductive and deductive approaches was used. In the process of psychometric evaluation of the questionnaire, face, content, construct and convergent validity and internal consistency of the questionnaire were assessed. Finally, 40 items of the questionnaire were covered by three factors: health satisfaction, concerns and complication. Four-point Likert scale was used for giving scores to this instrument. Some important variables affecting the patients’ quality of life which were previously neglected are considered in this questionnaire. Variables such as concerns about the possibility of transplant rejection, cost and complication of immunosuppressive drugs, recurrence of the underlying disease, and the need for transplant medical team follow-ups. It is clear that the use of this questionnaire instead of the common tools can be viewed as a more accurate criterion to assess the outcomes of liver transplants. Since solid organ transplant recipients have similar issues, this tool can be used with other transplant recipients, including kidney and kidney –pancreas recipients. However, there is a need to profoundly study this matter.Using a nonrandom sampling was the main limitation of this study. However, the descriptive statistics indicated that samples are quite diverse in age, sex, marital status, education level, and underlying diseases.