Background/Objective: Historically, fasting has been practiced not only for medical but also for religious reasons. Bahá’ís follow an annual religious intermittent dry fast of 19 days. We inquired into motivation behind and subjective health impacts of Bahá’í fasting. Methods: A convergent parallel mixed methods design was embedded in a clinical single arm observational study. Semi-structured individual interviews were conducted before (n = 7), during (n = 8), and after fasting (n = 8). Three months after the fasting period, two focus group interviews were conducted (n = 5/n = 3). A total of 146 Bahá’í volunteers answered an online survey at five time points before, during, and after fasting. Results: Fasting was found to play a central role for the religiosity of interviewees, implying changes in daily structures, spending time alone, engaging in religious practices, and experiencing social belonging. Results show an increase in mindfulness and well-being, which were accompanied by behavioural changes and experiences of self-efficacy and inner freedom. Survey scores point to an increase in mindfulness and well-being during fasting, while stress, anxiety, and fatigue decreased. Mindfulness remained elevated even three months after the fast. Conclusion: Bahá’í fasting seems to enhance participants’ mindfulness and well-being, lowering stress levels and reducing fatigue. Some of these effects lasted more than three months after fasting. Intermittent fasting (IF) and time-restricted eating (TRE) have gained increased awareness not only within the public community and media but also specifically within experimental and clinical research over the past decade . PublicaIn this study, we approached fasting using individual qualitative and focus group interviews, combining them with quantitative questionnaire data to highlight subjective experiences associated with fasting through a multifaceted approach. We chose a traditional religious fasting that is similar to the widespread fasting of Ramadan yet allows for easier replicability in terms of seasonal and daily practice time-frames . It alsoThe Bahá’í Fast (BF) can be regarded as a diurnal intermittent dry fast where followers abstain from food and drink during daylight hours for 19 consecutive days every year in March. In general, the main beliefs in the Bahá’í Faith revolve around the concept of unity in diversity, which is reflected in the relative simplicity of rituals . This caFasting has been part of many religious traditions of the past and the present. Most studies have focused on Ramadan fasting, showing multiple physical and psychological effects ,20,21,22In our previous publications on BF, we reported on the safety with no adverse changes in hydration indices observed. Effects found on our study population (n = 34) were a lowering of body mass index and total body fat mass as well as a reduction in blood glucose and HbA1c. The circadian phase estimated by transcript biomarkers of blood monocytes advanced by 1.1 h (n = 16) during fasting . An analIn the study arm presented here, we aimed to examine the immediate and long-term effects of a religiously motivated, temporal restriction of food and fluid intake on subjective health and well-being. We wished to obtain insight not only on how fasting changes participants’ lives during fasting but also on how people feel about and prepare for the fast as well as to understand its effects. Furthermore, we explored the nuances in motivation and importance to individuals undertaking this kind of fasting. We chose a mixed methods approach to better detail the complexity of the phenomenon, combining outcomes of qualitative individual and focus group interviews with selected survey data.The study data presented in this paper were collected as part of a larger, clinical longitudinal, self-controlled, exploratory cohort study conducted at the Charité—Universitätsmedizin Berlin including among other approaches a convergent parallel mixed methods design. The outcomes of the clinical and laboratory findings have been reported elsewhere ,34. QuesMixed methods combining quantitative and qualitative methods can increase understanding of complex issues and allow for the examination of findings from different vantage points (triangulation) . They arIn this study, we conducted questionnaires and interviews in parallel. Individual and focus group interviews were undertaken sequentially, the latter being implemented to verify the codes of the former. For an overview of the study timeline, please refer to The study was conducted at Charité—Universitätsmedizin Berlin. The interviews were conducted at the Department of Integrative Medicine at the Institute of Social Medicine, Epidemiology and Health Economics (IM) in a separate room that provided a quiet space for open discussion, and the questionnaires were distributed online via email. The timing of the visits is shown in For this study, 172 healthy Bahá’í volunteers were screened. Of these, 146 were considered eligible for the survey on patient-reported outcomes and were enclosed between January and February 2018. Further details as well as eligibility criteria have been published elsewhere . All eliThe interview sampling was chosen from this pool of participants. Individual interview and focus group sampling was based on the principle of maximum variation to balance gender and age. In accordance with theoretical sampling, the sample size was held flexibly and was iteratively determined by sample cohesion and saturation for the scope of this research ,39. FirsThe interviews were generally timed according to when the participants came for the other study visits before, during, and three weeks after the fast. Where this was not possible, suitable individual arrangements were made. For the semi-structured interviews at the baseline visit (V0), we developed a guideline based on clinical experience and previous research findings, without determining possible outcomes beforehand. The interview guideline focused on the meaning of fasting for the interviewees and its impact on their daily life and their perception of stress during and after the fast. Moreover, it contained questions on their motivation to fast and whether there were other aspects than religious motivators, the meaning and importance of communal activities and support during the fast, difficulties with fasting, and changes in dietary or other habits during the fast.As spirituality and religiosity are concepts that are being discussed intensively in qualitative research settings, they can be understood in different ways ,41, whicFor the following two interview rounds (V1 and V2), we created an interview guide focused on topics emphasised by interviewees at baseline, which is a typical procedure for qualitative interviews ,43,44. ETo validate the codes generated in the individual interviews, we conducted focus group interviews. Here, the group was encouraged to openly discuss the topics the participants chose to focus on ,46,47. TThe survey was conducted at five time points: before fasting (VQ0), on the first (VQ1) and third (VQ2) weeks of the fast, as well as three weeks (VQ4) and three months (VQ5) later , during (n = 8), and after fasting (n = 8). In total, 23 individual interviews were conducted. Three months after the fast, two focus group interviews were conducted to verify the codes developed from the individual interviews, with a total of n = 8 participants. A total of thirteen different participants were interviewed in the course of our study, either individually or in a group.We interviewed four women and four men aged 21 to 69 (P1–P8) individually. The main occupational characteristics that describe the interviewees follow: two students, a person on long-term sick leave, a teacher, a psychotherapist, an artist (freelancer), one geriatric nurse in training, and an office employee. At the first study visit time point (V0), we interviewed seven participants, and at the second study time point (V1), one more person was interviewed to balance out age. Therefore, three interviews were conducted with seven interview partners, and two additional interviews were conducted with the 8th participant. Out of these 23 interviews, the three interviews of one interview partner were excluded from the analysis, because the interviewee struggled with language comprehension, and interviews became too long and hard to understand, leaving space for misunderstandings and wrong interpretations. Therefore, 20 single interviews were included in the analysis.For focus group A, we recruited five interviewees, two women and three men, out of the pool of participants not having participated in the individual interviews. The main occupational characteristics that describe the focus group participants were an office employee, a former teacher, who had not been working for two years, two biologists, of whom one worked at a publishing house, and one chemist owning his own company. For focus group B, we recruited three former interviewees: two women and one man. Focus groups took place at time point V3.Questionnaires were sent out to 146 participants and collected at five separate time points: VQ0, VQ1, VQ2, VQ3, and VQ4. A description of the baseline characteristics of participants can be seen in From the individual interviews (I), we extracted 42 codes, which were summarised in three main categories: (A) grounded in religion, (B) elements of fasting, and (C) impacts of fasting. For the verification of these codes, the two focus groups (II) were conducted. During analysis, theoretical saturation was reached for the main topics of interest through our qualitative exploration and iteratively validated in the incremental elicitation and analysis process.(I).  Individual interviews(A).  Grounded in religionAll interviewed Bahá’ís described fasting as deeply grounded in their religion. Therefore, religiosity is a pervasive dimension that we differentiated in two categories, “Trust in God” and “Meaning of religiosity for fasters”, and briefly summarise below. For an overview of these results, see all religious commandments that He gives us as individuals and as society are good for us and lead us to progress (...). So, if He said to run up and down the stairs two at a time, I would do it!” .Religiosity was described as an expression of love, trust in, and connection to God. Some interviewees understood spirituality as part of their religious belief, a mental attitude of how to connect with and perceive nature and others. The motivation and endurance to fast was described to be based on lived religiousness, which included an inner mindset, a will for personal growth, as well as a marked dedication to religious ordinances. All interviewees viewed their behaviour as a deference to God’s directive and an expression of trusting in God’s word and his support. One interviewee even stated that “Three interviewees reported that submission to God’s will engendered the possibility to pass the responsibility over to God at the same time.I actually experience the scriptures as being the greatest support (...) and the providence that it (fasting) is a fixed component of Bahá’í life and included in these whole commandments is also this daily praying and meditating, which is intended throughout the whole year anyway, not only during the fasting period.” .Religious laws were seen by all interviewees as an inherent part of Bahá’í religious life, and fasting was described as a central part of those. To follow religious laws was either seen as a willing and voluntary submission to God’s will or as a duty. “a spiritual and religious exercise, leading you closer to God” . During the fast, interviewees emphasised focusing on their religion. Two-thirds reported feeling an improvement of their connection to God. The existence of the directive to fast was described as a supportive “cornerstone for daily life” .“I think too little about my religion during the year and during these 19 days, I think about it more. (...) I read more of the texts and can tell that it does me good…Like a homecoming.”Interviewees described religious laws as an “operating instruction” for personal growth . Religious fasting was described as “(B).  Elements of FastingWe identified four main prerequisites for the fasting period, as expressed by several interviewees: motivation, a sense of community, the opportunity to spend time alone, and a changed daily structure. MotivationAs participants expressed the belief in the benefit of God’s directives, they also expressed a high motivation to follow them. Repeating the fast annually was seen by all but one interviewee as reinforcing their described positive experiences, increasing their motivation to fast again. These experiences included physical well-being, a deepened feeling of religiousness and closeness to God, and an intensified feeling of connectedness with oneself. Additionally, some expressed the hope for a more conscious and healthier diet and a better-regulated eating behaviour. One person articulated the wish to lose weight, while another hoped for rejuvenating effects. Some of the interviewees mentioned feeling lighter in their body through fasting and hoped to reexperience this when fasting again. The outlook of an improved daily structure and seeing the fast as a chance to set goals for the upcoming year were also mentioned. Nevertheless, these elements were described as side effects that would not be important enough to fast were it not for the religious law.Changed daily structurereally totally different: nutritionally, sleepwise (…).” . Some interviewees explained that fasting helped them reduce distractions and use their time in a more systematic way. For six interviewees, it provided time to pray, read in the religious texts, and reflect on themselves, which was highly appreciated and valued during fasting. Challenges narrated by some interviewees were struggling to balance investment of time between the demands of the fast and other obligations. One interviewee struggled because of family life with young children, another because of homework for university. The latter reported suffering under the lack of time to focus on the fast while feeling pressured to work for university.As eating and drinking is allowed only between sunset and sunrise, all interviewees described this as the most substantial influencing factor of day-to-day structure. They woke up early enough to eat and, of particular importance to all interviewees, prayed before eating. For all interviewees, fasting created a structure that they normally did not have, which was described as beneficial by all but one. How intensely an individual experienced these structural changes as different from their normal life differed from person to person. While one interviewee did “not have to change [much], I just have to get up a little earlier” , another described that life was “Sense of communityExcept for one interviewee, all reported spending more time with their religious community, friends, or family during the fast. While the two youngest interviewees focused mainly on their Bahá’í friends during fasting, the older participants used the fast to connect with a wider network of friends, family, colleagues, or neighbours. According to four interviewees, communication with Bahá’ís and non-Bahá’ís allowed for new perspectives on the religious texts and their lives. Three interviewees reported that intellectual exchange with other Bahá’ís deepened insights in their religion; for one, it expanded her consciousness. Four interviewees mentioned that interaction with others helped them become aware of their pronounced irritability or impatience during fasting. Realising these tendencies was described as helpful, as the respective interviewees saw it as a chance to consciously change their behaviour. In addition to these valued aspects of socialising during the fast, three interviewees emphasised how breaking their fast in the evening in company made them eat more and heavier food and go to bed later than compared with eating alone, which made the next day more challenging. In contrast, four interviewees reported beginning the day with a collective breakfast followed by shared prayers and discussions on religious texts, which was described as very supportive and enjoyable, facilitating early rising.Opportunity to spend time aloneIt was very precious for me, at least the freedom to be alone (...) because I find that during the fasting period personal reflection is also very important (...). The introspection. And you cannot do that in company” . Meditating, praying, and reflecting on themselves and their lives were considered central elements of the Bahá’í fast by all interviewees. They reported changing their daily structure to make time to do so. While one of the two youngest interviewees did not profit from her time without the group at all and emphasised that she would have needed more time in community, the other one reported after the fast, that she had for the first time found out that time on her own was also very valuable. All other interviewees emphasised the importance of having time alone for self-reflection and prayers. One interviewee stated that he appreciated time in community but believes that “the way to the search for God needs to happen in solitude” .“(C).  Impacts of FastingInterviewees reported that fasting changed their individual behaviour. They described bodily changes, increased well-being and mindfulness, the experience of discipline and freedom, as well as changes in daily habits. -Experiencing physical consequences of behavioural changes during fastingI think it really is this experience! This bodily experience of consciously restricting something during the day and feeling what it does within the body, and that it is actually good” . Many interviewees enjoyed the feeling of an empty gut and physical lightness. Except for one interviewee, all reported drinking more than usual to avoid thirst during the daily fasting interval. Three interviewees emphasised how important it was that they went to bed early. During the fast, they discovered how lack of sleep had an intense negative impact on their physical condition. One interviewee linked the feeling of an empty, quiet stomach directly to feeling more energetic. Becoming aware of how their body felt while fasting heightened the perception of bodily changes. Interviewees reported employing different strategies to conserve their energy, e.g., moving more consciously and slower; being careful to avoid dizziness; working less or stopping earlier; and not talking much to avoid becoming thirsty.The limited amount of time allowed for food and fluid intake during fasting was said to lead to a shift of attention to normally mundane, incidental tasks. All interviewees discovered effects of their behavioural changes on their bodies and their well-being. “-Improved well-beingIt’s cool to fast, take a break, to tell the body: ‘now you’ll do something else (...)’ That’s good (...), you get out of your normal routine, your normal lifestyle, to step aside. And sometimes it hurts. But because it pushes you, gives you another pulse. That’s refreshing. That’s beneficial” . Early mornings, before sunrise in particular, were often mentioned as a very special and comforting time of the day. Three interviewees underscored feeling more energetic than usual after managing the first days of fasting. Although all interviewees reported being happy about fasting, three were unsatisfied with their external life circumstances during fasting but stated they were pleased to fast because they were following the word of God.All fasters reported being happy about fasting itself. Even though it was described as burdensome by one interviewee, still, he was glad that he had to focus on himself and his body and valued this experience. Fasting was perceived as a physical and spiritual cleansing by two interviewees. During the fast, three interviewees described feeling light and relaxed, which was caused by their focus on their religion, their increased introspection, and the physical sensation of an empty stomach. By not overeating, eating qualitatively good food, drinking more fluids than usual before and after breaking the fast, and sleeping enough, all but one reported feeling physically comfortable. One interviewee explained that only the fast reminded him of his body, which he stated not treating well enough in general. Although he reported suffering from lack of sleep, hunger, and tiredness during fasting, he perceived it as positive experience: “-MindfulnessThe whole body is subordinated to the spirit” . One interviewee stressed this freedom as an important outcome of fasting. Others emphasised a more transcendent experience in the sense of a higher sensitivity towards nature and entering a dream state of mind while awake. Four interviewees described learning to let go of more than only hunger and thirst. “This moment of letting go. That you notice how many things feel easier because of it. I think that also influences daily life, starting the day more relaxed.” . Accordingly, five interviewees described fasting as “a time where you become aware of what is central in life or where focus shifts on yourself.” . Two interviewees spoke extensively about finding one’s place in the world, a feeling described as being part of the larger order of the world, and saw fasting as a “recalibration of life” . Three interviewees reported a heightened awareness of their feelings and emotions, which helped them either to react more consciously, to not react but observe and reflect, or to feel more relaxed in stressful situations. All but one interviewee reported experiencing self-sufficiency and an increasing sense of empathy, becoming kinder and more affectionate. Additionally, one interviewee mentioned a renewed sense of inner balance: “I had this feeling of becoming one with myself again.” .Interviewees reported very different experiences of increased awareness of their body, their surroundings, and others. Three interviewees described benefits in the form of greater consciousness and awareness. By not eating, some interviewees mentioned they experienced freedom from physical, mundane needs: “-Discipline and freedomjust go to bed and wait for hunger to pass, sometimes” . The sense of hunger was reported by three interviewees to decrease after the first few days. Experiencing the ability to apply the required discipline to manage these challenges was reported by all interviewees to be a decisive factor for persevering during difficult times of fasting. Feeling good while fasting strengthened resolve: “If I can simply say ‘No, I can decide now’. Even if my body wants something else, then I am free.” . This effect was reported by three interviewees as one of the longest lasting, most crucial consequences of fasting with the largest influence on their general life, as they learned to decide more freely.Challenges were reported by all interviewees, especially during the first days of fasting, starting by missing the meal at lunchtime. Four interviewees felt tired and one felt cold. Although the Bahá’í fast is a dry fast, thirst was seen as a challenge only by two interviewees, one of whom reported having a dry mouth when speaking too much. However, five interviewees mentioned irritability due to hunger and reported strategies they developed to face this challenge, for example “-Changes in daily habitsDuring the fasting period, interviewees described measures they took to prepare for the fast, giving structure to their daily activities. Every interviewee had an individual way of preparation: two described a reduction in the amount of food intake one week before, another hid all her sweets, someone else planned his food shopping to avoid having to do a lot of it during the fast. One pre-cooked all meals for the whole fasting period, one planned which of the religious texts he would read during fasting. Two interviewees prepared mentally by increasing reflection on the upcoming fasting period. One interviewee reported having downloaded a prayer app on his smartphone to facilitate reading religious texts in the early mornings. Interviewees described starting preparations as early as January and as late as a few days before fasting. Just before the fast, there are a few days of Bahá’í festivities, which were valued as an important preparation by some interviewees. Interviewees reported changing different aspects of their eating behaviour during fasting. Every interviewee reported drinking more during fasting than before, and one person reported still drinking more even after the fasting period. All interviewees ate less. Some gave up sweets, chips, and other snacks during fasting and tried to make it last after the fasting period. One interviewee, who normally ate a lot of meat, increased the number of vegetables during fasting, another one focused on including more fruit in his diet. All but one interviewee reported enjoying food itself more, eating more slowly and consciously, and aimed to continue this after fasting. Only one interviewee described the change in his eating habits as difficult and not enjoyable.Nineteen days is not long, but it seems to be long enough to establish new habits” . Lasting effects varied individually, and most stated they did not expect being able to keep up all positive changes. Shortly after fasting, most interviewees still felt impacts of fasting on their behaviour. Changes in daily structure also allowed for more religious practices, which all wished to keep in their everyday lives. “Before fasting everything was very normal in daily life, daily routine patterns (…) During fasting, about different elements of life, somehow more reflected and deliberate. (…) And afterwards is when you try to keep it, or some elements of it or so. I am still trying to tweak some small parts, I would say.” .Four of the interviewees wished to integrate their new eating habits into their daily life after the fast, including the amount of food intake and, for one interviewee, regular eating times. The aim to change behaviour long-lastingly was reported to be an annual response to fasting: “(II).  Focus groupsFocus group B discussed fasting predominantly as a way of healing that is different from non-religious fasting because it includes not only physical but also spiritual aspects such as love and connection to God as an act of cleansing of the “outer” and “inner body”. Regarding changes experienced during fasting, focus group B talked extensively about drinking and eating habits. The main discussion points in this regard were not feeling a strong sense of thirst or hunger during the fast and enjoying eating less. They also discussed how changes in their eating habits continued beyond the fasting time.Focus group A focused more on changes of their daily structure, describing fasting as an exercise of detachment and emphasising the importance of having time alone for reading in the holy scriptures, praying, and meditating. Mainly driven by one interviewee, focus group B discussed more about religious aspects of fasting than focus group A.In the end it’s all a practice in letting go.” . “Through sacrifice of fundamentally different things in life, I gain greater consciousness.” .Both groups touched upon all main categories that were developed from the individual interviews. They talked about the importance of social support during the fast. The role of the family was emphasised, whose members may not be Bahá’ís but support the person fasting, in addition to the religious community. Experiencing discipline, challenges, and chances for personal growth were mentioned in both groups, such as increased well-being through fasting and the strengthened connection to God. Both groups discussed aspects of mindfulness enhanced by fasting, such as awareness and reflection of themselves and others, being more empathetic, and being able to let go of emotions: “p < 0.001). Quality of life improved during fasting (WHO5: p < 0.01), as did stress and anxiety symptoms . Measures of fatigue decreased during the fasting period . No significant effects were identified for SDHS, HADS depression, self-efficacy, vigour (POMS vigour), and displeasure (POMS Hostility). For more details, please refer to The positive effect on mindfulness was the most pronounced and sustained effect .Stress and anxiety showed a reduction in the questionnaires CSS and HADS anxiety, while in the interviews, the codes “trust in God”, “specific social environment”, and “opportunity to spend time alone” show different aspects of attitudes and behaviour, which could be interpreted to be conducive to this reduction.The ASKU questionnaire measuring self-efficacy showed high scores in our survey sample already at baseline and did not show significant changes during fasting. On the contrary, in the interviews, the topic of a rise in self-awareness and self-efficacy was mentioned under the codes “motivation” and “discipline and freedom”.While in the interviews, certain “changes in daily structure” are reported, which could result in a rise in fatigue, the questionnaires showed a decrease in fatigue during fasting (POMS fatigue).To our knowledge, this is the first mixed methods approach to Bahá’í fasting, exploring a wide variety of effects on the physical, emotional, and mental state of followers. The changes in daily routines and the experience of fasting in general appears to cause an increase in mindfulness and well-being, along with having a mild anxiolytic and stress-reducing effect. The findings on self-efficacy, on the other hand, seem to vary between qualitative and quantitative findings.Achieving higher levels of mindfulness through a dietary intervention such as fasting has not been previously described in the literature, to our knowledge. Mindfulness, embedded in meditation, was described by Kabat-Zinn as moment-by-moment awareness , while mThe stress-reducing effects of mindfulness, in addition to the anti-depressive and anxiolytic effects , could pRegarding self-efficacy, our qualitative and quantitative findings appear to be contradictory. The fact that the ASKU questionnaire does not show any significant changes may be related to the high scores that our sample had at baseline. On the flip side, one explanation may be a lacking sensitivity of the questionnaire to changes occurring in a short period of time. The rise in self-efficacy reported in the interviews is in line with findings by Maniaci et al. describing improved self-efficacy through a fasting-mimicking diet . IncreasWhat is striking in our results is the very positive connotation that fasting seems to have for Bahá’ís. In the past, historical research on eating disorders has discussed religious rules as one possible point of origin , raisingOur study has limitations we would like to address: in the qualitative part of this study, to a large extent analysed by two researchers (RR and CE), there is the possibility of an incorrect interpretation. However, within the research team, we tried to address this problem by creating inter-reliability through constant exchange and discussions about codes, categories, and theory with CE, NS, WS, BS, and DL and merging the results with those of the questionnaires. We also made use of natural language processing to verify our codes, the results of which will be published in another paper. In the questionnaire survey, we used some clinical questionnaires on healthy individuals, not suffering from any clinically relevant condition. This limited sensitivity of the questionnaires for the study population resulted in high baseline scores and non-significant results in some of them. Additionally, a selection bias is probable for both methods due to the voluntary participation in the study as well as a social desirability bias, as our sample seems to show a high sense of religiosity. This possible bias must be given even more weight given the absence of a control group. On the other hand, the repetition of the interviews and questionnaires over a relatively long period of time allowed for a certain reliability of the measured outcomes. In addition, having contacted all registered Bahá’ís in Germany through the official national mailing list augmented the representability of the sample.The long follow-up is a marked strength of this study, as is the synchronicity of sampling in both qualitative and quantitative methods. In addition, the use of focus group interviews to validate the codes stemming from the individual interviews and relatively large qualitative sample size add to the reliability of the data. This reliability is also reflected in the homogeneity of answers and the subsequent theoretical saturation of the interview outcomes.The results presented here supported the interpretation of the laboratory and physiological data we collected in the sample. For example, we had expected to see at least a slight dehydration during fasting, as those fasting would not drink during daylight hours for 19 consecutive days. Surprisingly, we saw no dehydration, and on the contrary, some participants had a better hydration than at baseline. Interviewees during fasting reported drinking more fluids in the morning and evening and being more conscious about their hydration than usual, making a behavioural change a probable cause for our laboratory findings. In addition, the time-shift of -1.1 h on average seen in the circadian phase could be explained similarly, as most interviewees reported having a meal before sunrise, this being earlier than their normal breakfast. As meal timing can have a strong influence on circadian rhythms, this could have contributed to the observed shift.Reflecting the outcomes reported in our paper on the religious aspects of BF , in lighCompared to Ramadan and other models of intermittent fasting, this type of fasting is relatively short and easy to undertake, and its safety was indicated by our laboratory findings . BF seem


Displacing the physiological model that had held sway in 19th-century medical thinking, early 20th-century hormone research promoted an understanding of the body and sexual desires in which variations in sex characteristics and non-reproductive sexual behaviours such as homosexuality were attributed to anomalies in the internal secretions produced by the testes or the ovaries. Biotypology, a new brand of medical science conceived and led by the Italian endocrinologist Nicola Pende, employed hormone research to study human types and hormone treatments to normalise individuals who did not conform to accepted medical norms. Latin American medical doctors, eugenicists, and sexologists took up biotypology with enthusiasm. This article considers the case studies of Italy, Argentina, and Brazil, and analyses the work of medical doctors who adopted a biotypological mode of reasoning and employed to various extents hormone therapies in their practice. By focusing on hormone therapies that aimed to normalise secondary sexual characteristics and the sexual instinct, the article suggests that while the existence of normality was contested to the point that a number of medical scientists argued that no such thing existed, the pursuit of normality was carried out in very practical terms through the new medical technologies hormone research had introduced. Discipline and Punish, Michel Foucault took the concept of normalisation to refer to an idealised norm of conduct, which was increasingly imposed through institutions such as prisons, schools, and asylums , which represented the foundational text of modern constitutional medicine in Italy, De Giovanni explained that normality was an exception in real life. In the third part of this text, entitled ‘Method That Aims to Determine the Value of the Morphological Individual Type’, De Giovanni stated, ‘The morphological type, as commonly understood, the type that should represent normality in every respect and that should be found in the majority of people, does not exist. The human morphological type, like the morphological type of race, is simply a concept’ .Modern constitutional medicine adopted a multifaceted approach to the clinic and varied from country to country. The so-called Italian School of constitutional medicine was particularly esteemed in both Europe and Latin America. It produced three generations of teachers and pupils who further advanced the discipline and defined and redefined the idea of type, normal type, and normality, using first anthropometry and statistics, and then hormonal formulae. More importantly for the argument developed here, this school produced a new science, biotypology, which employed the latest medical technologies, such as hormone treatments, to normalise individuals. The father of the modern Italian School of constitutional medicine was De Giovanni, professor of medical clinics at the University of Padua. In 1878, using anthropometric data that he had accumulated in his studies, he divided human beings into three different morphological types: (a) those with long limbs, a thin torso, and small diameters; (b) those with a developed torso, large diameters, and short legs and limbs; and (c) those with well-proportioned and harmonious measurements. Basically, De Giovanni described three constitutional human types according to the structure of the torso: brevilineal (short and fat), normotype , and longilineal . In his concept’ : 131.3 Hmaestro, introducing statistics. Viola adopted the statistical method that the Belgian mathematician, astronomer, and statistician Adolphe Quetelet had developed in the 1840s, and used it to study the body’s morphology. Quetelet had suggested that human traits fell along a Gaussian curve, or normal distribution. The ‘normal’ was the average  the sthenic longilineal; (b) the asthenic longilineal; (c) the sthenic brevilineal; and (d) the asthenic brevilineal : 88. Accbiotypology in 1922 and, in his own words, biotypology was the science ‘of the architecture and engineering of the individual human body’ , by clarifying that ‘normal individuals’ and ‘healthy individuals’ were two separate questions, he defined normality as the statistical average:human type—an abstract and ideal type that does not exist in Nature—is not the only type of healthy man. Many healthy subjects, we may even say the universality of healthy individuals, stray more or less from the statistical average normal type.…From the point of view of health and of functional robustness, wide deviations from the average type may exist. That is to say, individuals straying considerably from the normal average type—although within certain limits that cannot be established for all cases by bodily measurements—may nevertheless be healthy and functionally resistant. Accordingly, clinical normality, or health, and statistical normality, do not necessarily coincide.  included: the length of the thigh in relation to the length of the entire leg, the development of breasts, the width of the pelvis, the distribution of pubic hair, the voice, the menstrual cycle, and, of course, fecundity : 27. In Pende’s clinical experience showed that many subjects who were closest to the average type ‘very often present remarkable anomalies, especially in the genital and psychological spheres’ : 52. A cPende’s taxonomy of ‘genital states’, and his view that each human being at an embryonic level was hermaphroditic, tended more to undermine the stability of the two sexes than to affirm the existence of two stable and opposite sexes. If one also considers that, as mentioned above, normality and pathology were, according to Pende, merely quantitatively different, everything contributed to give the impression that all human manifestations of biological sex fell in a continuum. Pende’s books are populated by individuals who went beyond a clear dualism of male and female, and his numerous clinical cases of ‘hermaphoditism’ or ‘intersexuality’ seemed only to confirm this point. Yet, as I will show below, hormone treatments were meant to normalise these ‘genital states’ and to restore stability. Hormones, with their capacity to modify living bodies, presented the solution and offered the opportunity to reinstate order.But beyond Pende’s endocrine formula, or his theories and classifications of types, what is perhaps most interesting is the practical application of his work. Pende’s biotypology was not just an esoteric system of classification of types, having as it did highly practical implications and repercussions. The hormonal body, with its malleability, could be ameliorated in ways unthinkable before. Indeed, while extracts made from endocrine glands, especially testes and ovaries, had been employed for therapeutic and aphrodisiac purposes in both ancient Western and Chinese medicine, it was only in the 19th century that scientists started to experiment with these systematically on animals and human beings. In 1849, the German physician Arnold Berthold showed that testes discharged a chemical substance that affected other parts of the human body. Using roosters to carry out his investigations, Berthold revealed that after castration the roosters’ combs shrivelled, aggressive male behaviour disappeared, and they lost interest in hens. He also noticed that administering testicular extracts or transplanting testes could reverse the castration-induced changes : 12. Som6 To give a practical example, some Latin eugenicists, such as Pende, believed that changes in the individual’s environment could impact the endocrine glands, which would then secrete hormones that in turn would alter sex cells and, eventually, might be transmitted to offspring. An improved diet and more exercise, for instance, had a positive impact on hormones, and this strengthened the individual’s constitution. When factors such as diet and exercise were not enough, hormone treatments could correct the unbalanced functioning of the endocrine glands and transmit such corrections to future generations. In this sense, hormone treatments can be interpreted as eugenic forms of intervention.Historians such as Angus McLaren and Christer Nordlund have argued that hormone treatments in the interwar period came to be a way to practice eugenics . While, 7 Pende’s idea of orthogenesis was in line with the methods supported by Latin eugenicists. At first, the declared aim of the Biotypological Orthogenetic Institute was to screen the health and ethnic composition of the entire Italian population, and to rectify bodily anomalies and improve the Italian stock. It also functioned as a sexological centre, providing premarital counselling, evaluating racial unions, and favouring those that would, it reckoned, produce ‘fit’ offspring in the long term . This was a two-volume work that summarised the first two years of the institute’s activities, which focused on growth problems. The work presented about 100 case studies, most of them concerning children, teenagers, and young adults. The careful reader can detect differences in the ways in which Pende treated male and female case studies; in the case of men, Pende noted the penis volume, while he rarely commented on the size of women’s vaginas, instead noting the size of their breasts. Despite the fact that his works included tables that listed the ideal measurements for body parts . These were considered important characteristics in endocrinological works of the time, as they were used to corroborate whether the secondary sexual characteristics of the individual were typically male or female. Pende observed that Giovanni’s pubic hair had a ‘feminine distribution’, his testes were ‘flaccid’, and the penis developed. Yet when it came to Emma, he offered no description of her genitalia, only her breasts, which were described as ‘big’ (‘abbondanti’). He also recorded whether Emma and Giovanni masturbated and when they had first had sexual intercourse. In both cases, Pende’s treatment aimed to correct the secondary sexual characteristics, but only in Giovanni’s case was the opotherapy’s effect on his genitals deemed relevant.If we compare, for example, case studies of young female and young male adults contained in Biotypology came to inform much of the thinking about sexual and racial differences in Latin America and Southern Europe in the interwar period, with Argentina perhaps the Latin American country with the closest links to Italian biotypology. As Yolanda Eraso has pointed out, Argentinian enthusiasm for Italian biotypology in the 1930s stemmed from a common tradition of scientific thought that adhered to Lamarckian principles. Medical professionals in the two countries likewise shared the belief that it was possible to provide environmental interventions to improve their respective populations’ health, which in turn resulted in medical doctors’ advocacy of government intervention in areas such as hygiene and social medicine. Italian migration to Argentina also served to maintain strong cultural ties between the two countries. In 1914, the Argentinian census found that half the population in Buenos Aires was of foreign extraction  was founded, and this important journal was headed in turn by Rossi, López, and Gonzalo Bosch. The Anales was published every two weeks and functioned as an important hub for the circulation of biotypological ideas between the Northern and the Southern hemispheres. Pende, and other Southern European endocrinologists such as the Spaniard Gregorio Marañón, regularly contributed articles to this journal. In 1934, the association founded the Escuela Politécnica de Biotipología, Eugenesia y Medicina Social (Polytechnic School of Biotypology and Allied Matters), where students were trained in ‘biological eugenics and puericulture’ and in ‘legal and social eugenics’. Finally, in 1943, the Argentinian minister of justice and public education, Dr Guillermo Rothe, officially created a chair of biotypology in Buenos Aires and started a process that led to the nationalisation of the Instituto de Biotipología, Eugenesia y Medicina Social, which ultimately occurred in 1944 under a later minister of justice and public education, the medical doctor Gustavo Martínez Zuviría. Rossi led this new phase of the institute, which was renamed the Instituto Nacional de Biotipología y Materias Afines , and the School of Biotipology in Buonos Aires continued to train hundreds of graduate students each year until at least the 1960s , could be treated : 5. AlthSignificantly, in the 1930s, just as biotypology was flourishing in Argentina, physiological institutes, headed by the first Argentinian Nobel Prize winner, Bernardo Houssay, grew rapidly and achieved an international reputation. Crucial to this expansion was the significant economic support from the Rockefeller Foundation, which was interested in financing studies on endocrine hormones ‘that could illuminate issues of growth, body activities, behavior, old age and sexuality’ : 801. WiLa Prensa Medica Argentina. The first case, a study of a ‘diecenphalic feminilism’, was the most detailed, and describes the circumstances of José M., a 27-year-old single lithographer with an extremely weak constitution , Marañón interpreted a number of conditions, from ‘hermaphroditism’ to ‘sexual inversion’, as part of the same phenomenon. Although ‘hermaphoditism’ in Marañón’s work referred to what we now call intersex variations, and ‘sexual inversion’ to homosexuality, both were classified as ‘intersexual conditions’ whose origin was explicable through the working of hormones , Berardinelli wrote an article entitled ‘The Concept of Normality: The Personality or the Biotype’. He noted that the concept of normality was ‘highly relative’ in biology. On the one hand, normality was an ‘abstract idea’, as De Giovanni’s work on the ideal constitution had demonstrated. On the other hand, it was a concept based on a numerical standard, as in Viola’s studies on constitutions, which had applied Quetelet’s statistical method, whereby the average type resulted from the central values on the variation distribution curve  had had some value, but in nature true individuals excluded normality and there were only infinite variations of individuals (ibid.: 81).Rio de Janeiro in particular became a centre for biotypological studies. The University of Rio de Janeiro had an important school of constitutional medicine and biotypology led by Juvenil Rocha Vaz and Waldemar Berardinelli, both professors at the Faculty of Medicine : 82. In on curve : 80.11 AO Normotypo Brasileiro , a re-elaboration of his PhD thesis undertaken while working at the Gabinete de Biotipologia at the Faculty of Medicine of Rio de Janeiro, under the supervision of Juvenil Rocha Vaz. The book was dedicated to Brown’s maestri, Rocha Vaz and Berardinelli, and was awarded the Prêmio de Medicina pela Sociedade de Medicina e Cirurgia do Rio de Janeiro. Using Viola’s anthropometric method and Quetelet’s statistical methods, Brown aimed to find the Brazilian normal type , and of the Boletim de Educação Sexual , a journal that targeted a middle-class public , which was clearly influenced by biotypology, as the labels adopted to describe his patients indicate. When expounding his clinical cases, he employed categories such as brevilineal and longilineal constitutions. Irajá took normal sexuality to be reproductive sexuality, and in this book he openly spoke about hormone treatments that he had administered in an attempt to treat ‘sexual perversions’, including homosexuality. According to Irajá, anomalies of the sexual instinct could be hereditary , acquired, or a combination of hereditary and acquired. In his Tratamento dos males sexuales, he reported that in his career he had so far observed 100 cases of homosexuality, 70 male and 30 female, and that he had attempted to treat them through hormone therapies  before moving to Rio de Janeiro, where he became well known for his sexological writings, many of which targeted a popular audience. His book s public . In his herapies : 223. ToThe second case of male sexual inversion did not display feminine secondary sexual characteristics. The 29-year-old patient was originally from Germany and had an ‘athletic normo-type’ constitution, with normal body hair and a masculine voice and genitals. However, since childhood he had enjoyed wearing his sisters’ clothes, which sexually aroused him. Irajá’s treatment lasted three months, and the patient received a combination of 51 hormone treatments, psychoanalysis, and hypnosis. This case proved more successful than the first, as the German patient started to have sexual intercourse with women, although he was still attracted to men : 213–14.The third male sexual invert was a 68-year-old ex-soldier who was ‘almost normal’. His constitution was fine, but from time to time, generally when he had haemorrhoids, he could not resist having sexual intercourse with other men. His treatment consisted of a broad range of therapies, including bathing his genitals at 45 degrees twice a day, exposure to ultraviolet light, and galvanic electrical stimulation of the erogenous zones. For three months, this patient also received testes, prostrata, and renal cortex extracts, although all of these treatments proved unsuccessful : 215–16.Irajá also reported two cases of female sexual inversion. The first was L. S., a 25-year-old woman, single, with a ‘brevilineal’ constitution but masculine attitudes such as an aptitude for business and maths. She had not developed the secondary sexual characteristics typical for her age. She started to feel attracted to women when she was 10 years old, although at that age her attraction to members of the same sex was platonic. She began to menstruate at 17, and at that age she began having sexual intercourse with other women, as both an active and a passive partner. Irajá treated her with 40 injections of ‘gynhormon 50 u.r.’ ampoules (‘ampolle’) and 20 ampoules of hyphophists. While this led her to put on weight, her attraction to women continued. Irajá subsequently began a daily diathermic application to her hips to affect her ovaries, and while Irajá noticed some physical improvements, her homosexual inclinations did not change : 217–18.The second female case was a 40-year-old Italian who had a brevilineal constitution. While she possessed some facial hair, she was in fact married to a man, although she had felt attracted to women since she was 18 years old and had also had sexual intercourse with a range of different women. Irajá first treated the patient with 15 and then 30 thyroid extracts, along with a regime of general rest : 219. Heall primary and secondary sexual characteristics falling into the parameters of a standardised normality, did not exist in nature. When biotypologists set out to study the normal type in Latin America, where the racial composition was less homogeneous than in Southern Europe, 19th-century statistical methods and biotypological reasoning proved inadequate. Yet, with all the failings of their methodology, advocates of biotypology were so preoccupied with the numerical and the aesthetic parameters of the normal type that they ended up deriving endless taxonomies of variations from the norm in their attempts to define the normal type.As the historian of science Jean-Paul Gaudillière notes, ‘Normalizing human bodies is…always linked to the ability to define boundaries between the normal and the pathological’ : 528. YeWhile biotypology provided a tentative scientific foundation for arguing that a person did not match the ideal or normal type, endocrinological research made available the practical tools for normalising individuals who did not match the standard. Displacing the physiological model that had held sway in 19th-century medical thinking, in the 20th century hormone research promoted an understanding of the body in which ‘hermaphroditism’, homosexuality, and other ‘sexual perversions’ were all attributed to anomalies in the internal secretions produced by the testes or the ovaries. While the Argentinian Castex aimed to alter the physical characteristics of men with effeminate bodies, Brazilian sexologists such as Irajá employed hormone therapies explicitly to alter the sexual instinct. Medical techniques of normalisation such as hormone therapies, offering as they did post-natal interventions, conformed with Catholic precepts. Yet, as the Italian Orthogenetic Biotypological Institute made evident, such therapies were invasive eugenic treatments devised to improve the population.Testo Junkie that they initially started to take testosterone not to transition, but because they wanted to experiment with their body, this is indicative of how the same medical technologies that were intended to normalise people are now opening up a way to contest norm and normalisation alike (Finally, in the 20th century a number of new medical technologies were created, hormone treatments among them. Hormone treatments as carried out in the interwar period in Southern Europe and Latin America were designed to re-establish normality. When biotypologists and sexologists treated intersex and gay people with hormones, they aimed to restore standard male and female sexual characteristics, and heterosexual reproductive sexual behaviour along with them. Hormone treatments, in the practices analysed in this article, were designed to bring an individual closer to normality, whatever that was supposed to mean. Since the Second World War, the same medical technologies have increasingly made it possible to alter established and unquestioned concepts of normality. While there is still a trend towards using hormone treatment to normalise individuals and to bring their bodies to a state that is aligned with the accepted norms of male and female bodies, increasingly hormone treatments have offered possibilities of enhancement, experimentation, and even contestation. Hormone treatments, as embraced by some trans people, are defying binary views of sex, gender, and norms. When a trans philosopher such as Paul Preciado declares in their book on alike . It is p


Content analysis was used to examine perceived barriers and facilitators. Reported barriers included concerns about virus exposure in a hospital setting  or on public transportation , wearing a mask during sessions , lack of childcare , general transportation barriers , and the burden of planning and making time for in-person sessions . Reported facilitators included implementing and communicating safety protocols , conducting sessions at alternative or larger locations , providing incentives , and childcare and flexible scheduling options . This study identified a number of potential barriers and illustrated that COVID-19 has fostered and amplified barriers. Future interventions to facilitate resuming in-person sessions should focus on patient-centered strategies based on empathy regarding ongoing risk-aversion among perinatal patients despite existing safety protocols, and holistic thinking to make access to in-person psychotherapy easier and more accessible for perinatal patients.During the COVID-19 pandemic, outpatient psychotherapy transitioned to telemedicine. This study aimed to examine barriers and facilitators to resuming in-person psychotherapy with perinatal patients as the pandemic abates. We conducted focus group and individual interviews with a sample of perinatal participants ( Recent studies suggest that approximately 8 to 13% of women experience perinatal depression in Canada and the United States , and 15–During the pandemic, many medical interventions—including in-person psychotherapy with perinatal patients—were postponed, stopped, or altered to avoid in-person contact among staff, patients, and participants ,9. To coAlthough telemedicine has been an important avenue to deliver psychotherapy during the pandemic, reliance on telemedicine may create new and unforeseen barriers . For insIn consideration of resuming in-person sessions within the context of COVID-19, clinicians and clinical researchers may find that perinatal patients are a reluctant population because they may feel that they are a particularly vulnerable population . ConsequScaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial, which is aimed at increasing access to mental health treatment among perinatal patients with symptoms of depression and anxiety in Canada and the United States by delivering a form of psychotherapy called behavioral activation (BA) , and UNC Biomedical Institution Review Board (19-1786).The sample for this study included perinatal, provider, and stakeholder participants. First, perinatal participants were identified and then recruited for interviews in this current study from the SUMMIT trial, which recruited individuals who were 18 years of age or older and were either pregnant (up to 36 weeks) or postpartum (4 to 30 weeks) with depressive symptoms (EPDS ≥ 10). Exclusion criteria for the larger trial included non-English or non-Spanish speakers, individuals with active suicidal intent, active symptoms of psychosis or mania, and/or active substance abuse or dependence, individuals whose psychotropic medication dose or medication changed within two weeks of enrolment or beginning the BA sessions, individuals who are in ongoing psychotherapy, and individuals who experienced severe fetal anomalies, stillbirth, or infant death at the time of enrolment for index pregnancy . In the To be eligible to participate in our study, perinatal participants must have consented to be contacted to participate in qualitative research in the SUMMIT trial and must have completed at least 5 of the 6–8 BA sessions. Due to COVID-19, all perinatal participants in the current study received BA sessions via telemedicine. Among consenting perinatal participants, the SUMMIT research team identified and contacted a randomly selected subset of eligible perinatal participants willing to participate in this current qualitative study.Second, the provider group consisted of non-specialist providers (NSPs) and specialist providers (SPs) who delivered the BA sessions in the SUMMIT trial. NSPs were nurses and midwives with no previous mental health expertise that received training to deliver BA. SPs were psychotherapists, psychologists, psychiatrists, and social workers. To be eligible to participate in the current study, providers must have consented to participate in qualitative research through the SUMMIT research team who used convenience sampling to recruit and invite providers to participate in this current study via email.community-based stakeholders, including patient advocates, clinicians, community partners, and study consultants, and hospital-based stakeholders, which included psychiatrists, hospital administrators, and psychotherapists that SUMMIT researchers recruited from the trial’s three research sites. These stakeholders were included due to their robust knowledge, expertise, and experience working with patients both before and during the pandemic in relevant settings, such as in perinatal clinics and the hospitals where SUMMIT conducts the BA sessions, and because they have firsthand experience with the barriers that patients encounter and ways to facilitate resuming in-person activities. Stakeholders were contacts of the diverse SUMMIT team across study sites and were recruited by convenience sampling. Once recruited, the SUMMIT research team invited them to participate in this current study via email.Third, the stakeholder group comprised of TM.Data collection took place between August 2020 and March 2021. We conducted semi-structured individual and focus group interviews to examine our participants’ perspectives on what they foresee might be future barriers to resuming in-person psychotherapy sessions with perinatal patients. Then, we asked all participants their perspectives about potential facilitators to resuming in-person psychotherapy sessions with perinatal patients  as remuneration for their participation in the interviews. All participants were assigned an identification code, and any identifying details were obscured to maintain confidentiality.Trained research assistants audio-recorded the interviews, encrypted them for security, transcribed them verbatim, and checked their quality. Qualitative data were analyzed using NVivo™. Using previously established methodologies , we condn = 23), providers (n = 28), and a range of stakeholders (n = 18), across Canada and the United States . The barriers to resuming in-person psychotherapy sessions in the future that were specific to the COVID-19 pandemic were (1) concerns about virus exposure in a hospital setting, (2) concerns about virus exposure while taking public transportation, and (3) concerns about having to wear a mask during psychotherapy sessions see . The genn = 17 of 23, 73.9%), providers , and stakeholders  expressed that future participants may be reluctant to attend in-person BA sessions due to concerns about virus exposure in a hospital setting. These participants described that pregnant and postpartum patients might be particularly fearful of potentially contracting COVID-19 and transmitting it to their newborn and their families, especially at a hospital. For instance, a participant expressed that:Of the barriers reported by our participants that are specific to the COVID-19 pandemic, the majority of perinatal participants A provider also explained that:“Now that we’re in COVID, there’s going to be a lot of anxiety… Even [if they do not bring their] kids, my general sense is that there’s a fear of a hospital setting. I think that’s going to be a barrier... These waiting rooms are huge, packed, full of people, [which may be a deterrent for future participants]”.(NSP_06_Canada)Some perinatal participants expressed that if they were randomized to receive in-person sessions; they would be concerned about their safety at the hospital and choose to opt out:“I would be worried about COVID transmission, especially postpartum… I don’t think [future perinatal participants] would be very comfortable… I would not be very comfortable bringing my child into a session… So, if I had to go to the hospital in-person [for BA sessions], I would have chosen not to”.n = 6 of 23, 26.1%), providers , and stakeholders  described that future patients may be reluctant to attend in-person sessions because of the potential COVID-19 exposure while taking public transportation. One perinatal woman explained that:The second COVID-19-specific barrier was that perinatal participants “Transportation [would be a barrier] for clients who don’t have a car… [and] having to risk exposure on the bus or the train to get to the appointment” (SP_07_US). One Canadian stakeholder highlighted that this would be a barrier especially in the winter: “We have to think about our winters [since more people take transit in the winter rather than walking] and the risk of being on a very crowded transit” (Stakeholder_03_Canada).Likewise, a U.S. provider stated that: n = 3 of 23, 13.0%; providers n = 7 of 28, 25.0%; and stakeholders n = 9 of 18, 50.0%). Overall, participants expressed concern that wearing masks might impact the quality and experience of the BA sessions:“[An] obstacle [is] that it’s hard to imagine doing therapy in masks. It’s probably going to make it so impersonal. I would not want to do that” ; “If [the patient] is required to wear a mask in the common areas or even throughout the entire therapy, how does that feel to her? Is she okay with wearing a mask? Does that induce her anxiety?” (Stakeholder_05_Canada);The third COVID-19-specific barrier endorsed by our participants was needing to wear masks during BA sessions n = 10 of 23, 43.5%), providers , and stakeholders  expressed that future perinatal patients may be reluctant to attend in-person BA sessions because they do not have childcare: “This barrier is not COVID-related; it’s just always been a barrier that you can’t find childcare” (Stakeholder_12_Canada).Of the barriers reported by our participants that are not uniquely specific to the COVID-19 pandemic, perinatal participants . Similarly, a provider stated that, “we had childcare at [the hospital]” that parents could leave their kids at during psychotherapy sessions but that this was closed due to COVID-19 and explained that “I have no idea when that would be able to be opened up. I feel like it would be very long [in the future]. So, finding other childcare would be a big barrier” (SP_06_Canada).Although our participants expressed that childcare would be a challenge regardless of the pandemic, they asserted that regulations and safety concerns due COVID-19 has exacerbated this problem. For instance, there have been many periods during the pandemic in which children were not in school, daycares were closed, and babysitters or family members were unable to provide ad-hoc childcare. One perinatal participant said that “n = 11 of 23, 47.8%), providers , and stakeholders  also expressed that issues related to transportation, such as long drive times, traffic, not having access to a vehicle, and cost of parking, would be barriers for future perinatal patients to attend in-person sessions, regardless of the pandemic. One perinatal participant explained that “COVID aside, I’m [not in the same city as the hospital], so it’s quite a commute. And then you’re dealing with traffic and paying for parking. Those would be barriers for me” . A U.S. provider also said that:Perinatal participants (We have a lot of patients who have transportation [barriers] [and may not] even agree to participate in therapy because they can’t imagine how they would even get there if they’re a one-car family or a no-car family or they don’t want to take the bus with a child.(SP_05_US)One stakeholder highlighted that this barrier may be even more salient for low-income perinatal patients:We don’t have great public transportation options [in our city] because we’re much more spread out… and particularly for our lower income women, where you’re dealing with issues around cost and gas and all of those kinds of things, transportation will always be a barrier.(Stakeholder_20_US)n = 8 of 23, 34.8%), providers , and stakeholders  stated that new mothers are particularly busy and have many time constraints in general, which may prevent them from accessing in-person therapy. Planning and finding the time in their schedules to attend in-person sessions might be a barrier that is particularly relevant for perinatal populations, who are often managing multiple priorities and have many demands on their time:In addition to the barriers of finding childcare and the challenges of transportation, some of our perinatal participants I think one piece that doesn’t have to do with COVID at all, is just that pregnant and postpartum women are busy and have various competing demands, and it’s hard to get them to come in-person in general” (Stakeholder_13_Canada). A provider echoed this sentiment and stated that, “new moms have so many responsibilities… so they would have to multitask a lot [to come in-person] or just not have therapy” (NSP_02_US).Similarly, a stakeholder explained that: “All participant groups were asked about facilitators to resuming in-person psychotherapy with perinatal patients. The facilitators to resuming in-person psychotherapy sessions in the future that were specific to the COVID-19 pandemic were (1) implementing and communicating robust safety protocols and (2) having sessions at an offsite location, not so deep within the hospital, or in larger rooms see . Our parwe’d have to be able to provide some kind of assurance of safety in educational materials that were provided to the patients along with theirSUMMIT orientation, explaining why in-person was a safe option” (NSP_01_US). Perinatal and stakeholder participants also suggested the following:Implementing and effectively communicating robust safety protocols was a facilitator suggested by 11 (47.8%) perinatal participants, 11 (39.3%) providers, and 13 (72.2%) stakeholders. Participants suggested that information could be disseminated to patients to address patients’ anxiety about coming to the hospital. A provider said, ““Definitely let the patient know [what] the plans [is for] cleanliness, ‘this is what we do, this is our procedure, you don’t have to see anyone, you just come in, you don’t have to touch anything, we’re going to be 6 feet apart, there is a partition [or] Plexiglas.’ Just reassuring them on that end”.Specifically, a stakeholder suggested that:“A way to decrease the fear and anxiety is to create a little info booklet or package that we can give to people that are consenting to in-person... [on] the use of masks and all of the stuff…to help reduce any of those issues”.(Stakeholder_07_Canada)Maybe [have sessions] in a larger room where you can distance even more than six feet apart” (Stakeholder_17_Canada).Another facilitator suggested by 4 (17.4%) perinatal participants, 9 (32.1%) providers, and 8 (44.4%) stakeholders was to provider alternative locations to where sessions are delivered, such as rooms that are not so deep inside the hospitals or in larger rooms where participants can socially distance or be separated by Plexiglas. For instance, participants suggested that holding sessions in a larger room could address barriers to attending in-person psychotherapy, such as concerns about having to wear masks: “I think patients would be more interested in coming to some sort of outpatient facility or not the hospital, like a private office somewhere … Of course, there’s cost implications and cleaning and all these things [to consider]” (SP_07_US).Participants suggested that conducting the BA sessions on the first floor of the hospital, or even offsite at a non-clinical location, may be a facilitator for resuming in-person psychotherapy sessions: “A perinatal participant also suggested that:“Instead of walking through a busy lobby, taking the elevator up, [I’d prefer] a room on the first floor as close to the door as possible [and] one person [goes in] at a time. That would be great… Walk[ing] through a healthcare facility… would be super nerve-wracking…I had to take an elevator [to see my doctor], and I was panicked for three days after”.gas and parking is so expensive, so maybe if there’s free parking or a parking voucher [that would an incentive].” Similarly, one of the stakeholders expressed that “For some, it’s a financial burden [to travel]. So, paying for parking if they’re coming from far away [would reduce that barrier] (Stakeholder_14_Canada). A U.S. provider also emphasized that a “taxi, bus token, or parking voucher” would be a particularly beneficial incentive and would help reduce the transportation-cost barrier “for lower-income folks” who may find such costs particularly burdensome.In order to mediate general transportation barriers, such as long drive times, traffic, not having access to a vehicle, and cost of parking, 8 (34.8%) perinatal participants, 6 (21.4%) providers, and 2 (11.1%) stakeholders suggested providing incentives, such as transportation or parking vouchers. A perinatal patient explained that: “If you had somewhere where you could bring your children or if the mom could bring her infant and children with her and somebody there or right next door [is there] to help watch, that would be very beneficial” .To further reduce barriers for perinatal patients to attend in-person therapy, 9 (31.1%) perinatal participants and 3 (16.7%) stakeholders suggested that there will be a need to increase accessibility to therapy by providing childcare at the hospital and having flexible time slots for sessions. Although this theme was reported by fewer participants, participants who did report this theme provided practical and creative solutions to improving access for perinatal patients to resume in-person sessions, such as allowing perinatal patients to bring children with them, resuming on-site daycare, and having flexible or extended session times to allow for perinatal patients to work around their families’ schedules. For instance, one U.S. perinatal participant said that: “One stakeholder also suggested working with the patient to schedules times when they are already coming into the hospital to make attending sessions feel less burdensome in their busy schedule:“Another [thing that can be done is ask]: does the patient already have visits that they need to come to for other reasons that we couple them together? So that [the patient] can be like, ‘hey, I have to go into [the hospital/clinic] anyway to pick up a prescription (or whatever it is), and then I can just do this, so I’m not having to come twice?’”.(Stakeholder_17_Canada)We examined perceived future barriers to resuming in-person psychotherapy sessions with perinatal participants amid the COVID-19 pandemic. We anticipated that examining perceived barriers would produce important insights to perinatal patients’ decision-making practices regarding accessing in-person care. We then examined potential facilitators to resuming in-person psychotherapy sessions with perinatal patients with symptoms of depression and anxiety.A key finding that emerged was that the majority of perinatal, provider, and stakeholder participants in the current study expressed a number of barriers to resuming in-person psychotherapy sessions that were specific to the COVID-19 pandemic, which included perinatal participants’ concerns about virus exposure in a hospital setting, virus exposure while taking public transportation, and having to wear a mask during psychotherapy sessions. Participants also expressed that there would be key barriers for perinatal patients regardless of the pandemic. These barriers were lack of childcare, general transportation barriers such as not having access to a vehicle and the high cost of parking at hospitals, and the burden of planning and making time to attend in-person sessions at a hospital while navigating other priorities. Based on participants’ responses about these barriers that might exist regardless of the pandemic, it became apparent that barriers, such as a lack of childcare, have been amplified by the ongoing pandemic.Perinatal participants, providers, and stakeholders all suggested two ways to facilitate resuming in-person psychotherapy sessions that are related to the aforementioned barriers that were specific to COVID-19. The first suggested strategy was to implement and clearly communicate robust safety protocols to patients that is supported by research, health officials, and policy advisors across the globe, emphasizing the importance of basic safety protocols, such as requiring masks, promoting social distancing in spaces such as public transportation, and employing hand hygiene when accessing public spaces ,26.While many safety procedures are already in place at healthcare sites, our findings suggest that patients, and potentially their providers, may not be well informed about them or these procedures may feel unclear or difficult to access to patients. Thus, finding ways to clearly and effectively communicate safety protocols to perinatal patients and providers will be of particular importance. These findings are consistent with previous research that underscores that patients and providers tend to feel overwhelmed when unclear messages and guidelines about health and safety exist ,28. StudOur solution-focused findings confirm that clear, patient-centered communication strategies will be key to informing best practices and policies when resuming in-person psychotherapy sessions amid the COVID-19 pandemic. Patient-centered communication has been shown to help improve trust in healthcare institutions, services, and providers . A patiehttps://www.flipsnack.com/E88FE7AA9F7/in-person-brochure_provider.html accessed on 22 May 2021). This information should include clearly outlined safety protocols written in straightforward terms, and should ideally be available in multiple languages when applicable. Other strategies may include providing patients with clear instructions about where to go within the hospital, allowing perinatal patients to wait outside or in their car where they can be called or sent a text message to avoid busy waiting rooms, to clearly articulate whether perinatal patients are allowed to bring infants and children to the location of their sessions, whether the location and room are stroller-friendly and large enough to fit patients and strollers in light of social distancing requirements, having COVID-19 screening calls prior to patients traveling to their sessions and guidelines on what to do if screens are positive, and incorporating non-punitive protocols for cancellations [Based on our study and population, we propose that some of the best communication practices and strategies may include providing physical information sheets and access to a website or an online PDF outlining what patients can expect when they go to in-person psychotherapy sessions (Available online: llations ,26. WhenThe second suggested strategy was to conduct psychotherapy not deep within the hospital setting, and also in larger-sized rooms. This suggestion may not be feasible for some psychotherapist clinicians and clinical studies. Nonetheless, perinatal patients may feel a sense of heightened anxiety of being exposed to COVID-19 while pregnant or exposing their newborn, and may also be concerned about having to wear a mask during sessions in general or needing to briefly remove their mask to use a tissue if they cry during sessions . TherefoIn addition to the COVID-19-specific facilitators, our participants suggested two ways to facilitate resuming in-person psychotherapy sessions to overcome general barriers to transportation costs and the burden of seeking childcare and having to plan and make time to participate in in-person psychotherapy. First, our participants suggested providing incentives, such as transportation or parking vouchers, that may lessen some of the financial transportation burdens. This facilitator is particularly relevant for clinical researchers who may have access to funding. Clinicians aiming to improve access to perinatal mental healthcare may also want to work with hospital leaders and administrators to find solutions to minimizing the financial burdens for perinatal patients visiting the hospital. Although our results pertain to perinatal patients, this suggestion is useful and relevant for providers working with patients who are low-income to whom the burden of paying high costs for parking may make them less likely to access in-person care.Perinatal participants and stakeholders also suggested improving access to in-person psychotherapy by providing childcare and holding extended or flexible time options for sessions. Informing perinatal patients that they are able to bring their infants with them to sessions would minimize the barrier of finding childcare, ensuring that there is a private, safe, and comfortable space for perinatal patients to breastfeed, and having flexible scheduling options to patients can work around when they have access to childcare are all straightforward, patient-centered recommendations to facilitate resuming in-person sessions with this population . As the Although the barriers and facilitators discussed in this study directly pertain to resuming in-person psychotherapy within the SUMMIT trial, they can also be extrapolated to other clinicians and clinical research trials that are aiming to resume in-person psychotherapy sessions. Similarly, our findings can be used to inform practices to make in-person psychotherapy more patient-centered for perinatal patients with symptoms of depression and anxiety. This approach aims to make health equity for perinatal patients with symptoms of depression and anxiety a priority in research and practice .Furthermore, COVID-19 may continue to impact patients’ and study participants’ decisions to attend in-person psychotherapy, but so might the normalization and benefits of virtual care. Due to the pandemic, telemedicine became a common practice for delivering psychotherapy ,10,13. HThis study has a few limitations. The first limitation is that we did not collect demographic data for our stakeholder group. Second, given our participants were living in different jurisdictions, our findings cannot account for how variations in local government regulations impacted our participants’ responses, such as the Stage two and Stage three reopening in Toronto in late summer and fall of 2020, and subsequent lockdown order at the end of November 2020. Third, future research should also examine how socio-demographic factors might impact perinatal patients’ attitudes and beliefs about barriers and facilitators to transitioning to in-person psychotherapy.A key strength of this research is that we have identified key barriers and facilitators across three key and distinct participant groups of patients, providers, and stakeholders, which strengthens our findings by producing recommendations and insights from diverse perspectives . Our proThis paper drew on multistakeholder, qualitative data to examine the relevant factors to resuming in-person psychotherapy sessions with perinatal patients. This study found that COVID-19 has fostered a number of potential barriers to resuming in-person psychotherapy, and has likely exacerbated existing barriers, such as finding childcare and the burden of having to plan and negotiate competing priorities. However, the most reported facilitators focused on those that mediate COVID-19-specific barriers. Although facilitators such as implementing safety protocols are in-place in healthcare settings, our results suggest that there is a gap between the existence of such protocols and how perinatal patients might assess their level of risks when asked to access healthcare locations for in-person psychotherapy. Despite existing safety protocols and low rates of COVID-19 transmissions in hospitals, there is the perception that perinatal patients will nonetheless feel less safe and our findings suggest that this belief is likely to be attributed to perinatal patients who may feel particularly vulnerable while pregnant or fearful of exposing their newborn. Future interventions to facilitate resuming in-person sessions should focus on compassionate, patient-centered strategies and be aware of the need to address key barriers to resuming in-person therapy, in which providers and researchers take seriously the potential for ongoing risk aversion among perinatal patients.For perinatal patients who are already experiencing depression and anxiety, reluctance to participate in in-person psychotherapy and clinical trials as the pandemic abates may be more acute. Our findings are benefited by the consensus between our three participant groups. Our findings highlight critical, feasible facilitators for resuming in-person psychotherapy: the need to implement safety protocols and develop clear, accessible, and patient-centered strategies to communicate to patients and research participants the many steps being taken to maintain their health and safety, as well as to find straightforward solutions, such as holding flexible and extended session times for this population.