Effectiveness, Mediators, and Effect Predictors of Internet Interventions for Chronic XXXX : The Design and an Analysis Plan of a 3-Armed Randomized Controlled Trial.

@entity5 @entity1 @entity1295
BACKGROUND: Internet interventions offer advantages that especially @entity5 survivors who suffer from @entity1295 could benefit from. Given the growing number of such @entity1 , Internet interventions could supplement and strengthen currently available health care. OBJECTIVE: This paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe @entity1295 in @entity5 survivors: a mobile ambulant activity feedback therapy supported through a weekly email by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore @entity1 characteristics that can predict the effect of these interventions. METHODS: A 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational emails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, @entity1 in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of @entity1295 severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over @entity1295 are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through @entity1 organizations and their websites, newspapers, and by informing various types of health professionals. All @entity1 register at an open-access website. We aim at including 330 @entity5 survivors who have finished curative-intent @entity5 treatment at least 3 months previously, and have been suffering from severe @entity1295 ever since. All @entity5 types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design. RESULTS: Recruitment started in April 2013 and will proceed until April 2015. CONCLUSIONS: This paper describes a systematic trial design for studying 2 different interventions for chronic @entity5 in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions' effect on @entity1295 . By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).
