Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV).

BACKGROUND: Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence. AIMS: With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions. METHOD: We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity. CONCLUSIONS: The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

Factors influencing the duration of untreated illness among patients with anorexia nervosa: A multicenter and multi-informant study.

INTRODUCTION: The duration of untreated illness (DUI), that is, the interval between the onset of anorexia nervosa (AN) symptoms and start of specialized treatments, has a strong influence on the prognosis. OBJECTIVE: To quantify modifiable predictors of the DUI and to derive recommendations for secondary prevention strategies. METHODS: Within a multicenter, multi-informant study, DUI was assessed in interviews with patients undergoing first specialized AN treatment. Modifiable factors were assessed perspectives of AN-patients, their relatives, and primary care practitioners [PCPs]) with the FABIANA-checklist (Facilitators and barriers in anorexia nervosa treatment initiation). The effect of FABIANA-items on the DUI for each perspective was calculated using Cox Regression (control variables: age, eating disorder pathology, health care status, migration background, body mass index [BMI]). RESULTS: We included data from N = 125 female patients with AN (72 adults, 53 adolescents, Mage = 19.2 years, SD = 4.2, MBMI = 15.7 kg/m2 , SD = 1.9), N = 89 relatives (81.8% female, 18.2% male, Mage = 46.0 years, SD = 11.0) and N = 40 PCPs (Mage = 49.7 years, SD = 9.0). Average DUI was 12.0 months. Watching or reading articles about the successful treatment of other individuals with AN (patients' perspective) and regular appointments with a PCP (PCPs' perspective) were related to a shorter DUI (HR = 0.145, p = .046/ HR = 0.395, p = .018). Patients whose relatives rated that PCPs trivialized patients' difficulties had a longer DUI (HR = -0.147, p = .037). PCPs and relatives rated PCPs' competence higher than patients did. DISCUSSION: It is recommended (a) to incorporate treatment success stories in prevention strategies, (b) to inform PCPs about potential benefits of regular appointments during the transition to specialized care, and (c) to train PCPs in dealing with patients' complaints. PUBLIC SIGNIFICANCE: Many individuals with AN seek treatment very late. Our study shows that a promising approach to facilitate earlier AN treatment is to inform patients about successful treatments of affected peers, to foster regular appointments with a PCP and, to motivate these PCPs to take individuals' with AN difficulties seriously. Thus, our study provides important suggestions for interventions that aim to improve early treatment in AN.

Beliefs about emotions predict psychological stress related to somatic symptoms.

BACKGROUND: Previous research has shown that the more people believe their emotions are controllable and useful (BECU), the less they generally report psychological distress. Psychological distress, in turn, impacts health outcomes, and is among the most frequently reported complaints in psychotherapeutic and psychosomatic practice. OBJECTIVE: We aimed to examine how BECU predicts psychological distress related to somatic symptoms in a prospective sample from the general population and to replicate this association in two cross-sectional samples of psychosomatic patients. METHODS: We applied a panel design with an interval of 2 weeks between T1 and T2 in general-population panel-participants (N = 310), assessing BECU and psychological distress related to somatic symptoms via validated self-report measures. Moreover, we cross-sectionally replicated the relationship between BECU and psychological distress in a clinical sample of psychosomatic outpatients diagnosed with somatoform disorders (n = 101) or without somatoform disorders (n = 628). RESULTS: BECU predicted over and above the lagged criterion panel-participants' psychological distress related to somatic symptoms, ß = -.18, p < .001. BECU was also cross-sectionally related to psychological distress in our clinical replication-sample of psychosomatic outpatients diagnosed with somatoform disorders, rS (87) = -.33, p = .002 and in those without, rS (557) = -.21, p < .001. CONCLUSIONS: BECU as a malleable way of thinking about emotions predicted psychological distress related to somatic symptoms in general-population panel-participants and correlated with the same in two clinical replication samples. BECU thus becomes a promising treatment target in psychotherapeutic approaches.

Healthcare-related factors influencing symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms: A scoping review of European studies.

OBJECTIVE: This scoping review explored healthcare-related factors associated with symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms (PSS) across Europe. METHODS: Articles were systematically searched in PubMed, Web of Science, Cochrane Library, and PsycINFO by combining terms of PSS and healthcare-related factors. Studies published in English, German, Polish, or Dutch between 2000 and 2022 were included. Healthcare-related factors associated with PSS symptom course were investigated, and study quality assessed (Center for Evidence-Based Medicine Checklist, Newcastle-Ottawa Scale). RESULTS: Of 8386 identified studies, 56 were included in the analysis. A significant knowledge gap was evident, as most studies lacked comprehensive healthcare descriptions with particularly unclear definitions of "treatments as usual" in RCTs. The only extractable healthcare factor according to Andersen's Behavioral Model was the treatment setting. Rates of PSS improvement split by care-levels were 38% in primary, 44% in secondary, 25% in mixed, and 71% in specialized care. Persistence rates were 57%, 50%, 75%, and 29% respectively. Deterioration was observed in 5% of primary and 6% of secondary care studies. Studies were skewed toward the United Kingdom, Germany, and the Netherlands. CONCLUSIONS: This scoping review shed light on the association between care levels and symptom outcomes in PSS patients. However, limited information in the current studies constrained our exploration of associations with other factors and symptom outcomes. Important aspects, like care availability, referral processes, and insurance coverage, are yet to be elucidated. Addressing these gaps is pivotal for developing targeted treatments across Europe, ultimately enhancing PSS patients' outcomes.

Helpful explanatory models for persistent somatic symptoms (HERMES): Results of a three-arm randomized-controlled pilot trial.

OBJECTIVE: This three-arm randomized controlled trial aimed to test the efficacy of an etiological model for persistent somatic symptoms (PSS) translated into video-animated explanatory models in comparison to a control group, and to examine additional value of personalization of the explanatory models (i.e. possibility to choose information based on mechanisms of symptom persistence). METHODS: Outpatients with PSS were shown one of three 15-min video animations: a) explanatory model without personalization, b) explanatory model with personalization, c) no explanatory model control group. Changes in somatic symptom severity (PHQ-15) and psychological burden related to somatic symptoms or associated health concerns (SSD-12) from baseline to one-month follow-up were the primary outcome. Health-related quality of life (SF-12) and perceived usefulness (USE) were also assessed. RESULTS: Seventy-five patients with PSS were allocated to the study arms (Mage = 44.2 ± 13.3 years, 56% female). The study arms did not differ significantly on the primary outcomes. However, no explanatory model participants reported significantly greater mental quality of life improvements than explanatory model without personalization participants (Mdiff = 7.50 [0.43; 14.56]). Further, explanatory model with personalization participants rated the individual fit of the intervention significantly higher than no explanatory model participants (Mdiff = 2.05 [0.17; 3.93]). All groups rated credibility of the intervention as very high. CONCLUSION: The HERMES materials seemed to have been too brief to improve symptom related outcomes. However, all three interventions were positively evaluated regarding their usefulness, particularly in case of additional personalization. Future studies should investigate potential effects of an increased intervention dose. TRIAL REGISTRATION: DRKS00018803.

Patients' acceptance of explanatory models for persistent somatic symptoms: A qualitative analysis within the HERMES study.

OBJECTIVE: The aim of this qualitative study was to provide an in-depth analysis of participants' experiences with video-animated explanatory models developed within the three-arm randomized controlled HERMES study ('Helpful explanatory models for somatic symptoms') and suggestions for further intervention improvement. METHODS: Semi-structured qualitative interviews were conducted with psychosomatic outpatients with persistent somatic symptoms (PSS) after they were randomized to view one of three psychoeducational videos on a tablet computer: a) an explanatory model without personalization or b) an explanatory model with personalization in the two experimental groups or c) PSS guidelines without an explanatory model in the control group. Qualitative interviews were audiotaped, transcribed and analyzed applying thematic analysis. RESULTS: Seventy-five patients with PSS were allocated to the study arms, mean duration of interviews was 8.19 min (SD = 3.19, range 4.02-19.49 min). Although all participants gave positive feedback regardless of their allocated study arm, those in the explanatory model without and with personalization groups were especially likely to rate the psychoeducational interventions as helpful. Results highlighted previous illness course, symptom perceptions and patient characteristics as key factors related to patients' response to the video interventions and optimal personalization of the explanatory model. CONCLUSION: The present study not only demonstrated the acceptance of all three psychoeducational interventions developed within the HERMES study, but also provided valuable insights into potential key factors that may increase their impact and potential starting points for tailored psychoeducation in patients with PSS.

Absence of self-reported neuropsychiatric and somatic symptoms after Omicron variant SARS-CoV-2 breakthrough infections.

Persistent somatic and neuropsychiatric symptoms have been frequently described in patients after infection with severe acute respiratory syndrome coronavirus 2 even after a benign clinical course of the acute infection during the early phases of the coronavirus severe acute respiratory syndrome coronavirus 2 pandemic and are part of Long COVID. The Omicron variant emerged in November 2021 and has rapidly become predominant due to its high infectivity and suboptimal vaccine cross-protection. The frequency of neuropsychiatric post-acute sequelae after infection with the severe acute respiratory syndrome coronavirus 2 Omicron and adequate vaccination status is not known. Here, we aimed to characterize post-acute symptoms in individuals with asymptomatic or mildly symptomatic breakthrough infection with severe acute respiratory syndrome coronavirus 2. These individuals had either proven infection with the Omicron variant (n = 157) or their infection occurred in 2022 where Omicron was the predominant variant of severe acute respiratory syndrome coronavirus 2 in Germany (n = 107). This monocentric cross-sectional study was conducted at the University Medical Center Hamburg-Eppendorf between 11 February 2022 and 11 April 2022. We employed questionnaires addressing self-reported somatic symptom burden (Somatic Symptom Scale 8) and neuropsychiatric symptoms including mood (Patient Health Questionnaire 2), anxiety (Generalized Anxiety Disorder 7), attention (Mindful Attention Awareness Scale) and fatigue (Fatigue Assessment Scale) in a cohort of hospital workers. Scores were compared between 175 individuals less than 4 weeks after positive testing for severe acute respiratory syndrome coronavirus 2, 88 individuals more than 4 weeks after positive testing and 87 severe acute respiratory syndrome coronavirus 2 uninfected controls. The majority (n = 313; 89.5%) of included individuals were vaccinated at least three times. After recovery from infection, no significant differences in scores assessing neuropsychiatric and somatic symptoms were detected between the three groups (severe acute respiratory syndrome coronavirus 2 uninfected controls, individuals less and more than 4 weeks after positive testing) independent of age, sex, preconditions and vaccination status. In addition, self-reported symptom burden did not significantly correlate with the number of vaccinations against severe acute respiratory syndrome coronavirus 2, time from recovery or the number of infections. Notably, in all three groups, the mean scores for each item of our questionnaire lay below the pathological threshold. Our data show that persistent neuropsychiatric and somatic symptoms after recovery from severe acute respiratory syndrome coronavirus 2 infection in fully vaccinated hospital workers do not occur more frequently than that in uninfected individuals. This will guide healthcare professionals in the clinical management of patients after recovery from breakthrough infections with severe acute respiratory syndrome coronavirus 2.

Predictors of somatic symptom burden in healthcare professionals during the COVID-19 pandemic: an 8-week follow-up study.

BACKGROUND: Literature investigating the impact of COVID-19 on healthcare professionals barely addresses predictors of somatic symptom burden during the COVID-19 pandemic. AIMS: As biopsychosocial models propose that not only the disease but also sociodemographic and psychosocial factors contribute to the development and maintenance of symptoms, this study investigates the predictive value of these factors for bothersome somatic symptoms in SARS-CoV-2 negative healthcare professionals. METHODS: German healthcare professionals were assessed with self-rating questionnaires and underwent SARS-CoV-2 IgG antibody tests at baseline and 8 weeks later between April and August 2020. Differences in psychosocial variables between the time points were analyzed and regression analyses were performed to predict somatic symptoms at follow-up. RESULTS: 1185 seronegative healthcare professionals completed both assessments. Previous somatic symptom burden, higher levels of anxiety, being a nurse, younger age, higher psychological symptom burden, lower efficiency, and higher fatigability at baseline predicted somatic symptom burden at follow-up. Comparisons between baseline and follow-up showed a significant improvement in psychological impairment and deterioration of physical exhaustion. CONCLUSIONS: Our study applies a biopsychosocial perspective to bothersome somatic symptoms during the COVID-19 pandemic and contributes to the identification of potential risk factors as a starting point for future interventions that could support the handling of symptoms.

Risk factors for worsening of somatic symptom burden in a prospective cohort during the COVID-19 pandemic.

Introduction: Little is known about risk factors for both Long COVID and somatic symptoms that develop in individuals without a history of COVID-19 in response to the pandemic. There is reason to assume an interplay between pathophysiological mechanisms and psychosocial factors in the etiology of symptom persistence. Objective: Therefore, this study investigates specific risk factors for somatic symptom deterioration in a cohort of German adults with and without prior SARS-CoV-2 infection. Methods: German healthcare professionals underwent SARS-CoV-2 IgG antibody testing and completed self-rating questionnaires at baseline and 21 months later between April 2020 and February 2022. Differences in variables between the time points were analyzed and a regression analysis was performed to predict somatic symptom deterioration at follow-up. Results: Seven hundred fifty-one adults completed both assessments. Until follow-up, n = 58 had contracted SARS-CoV-2 confirmed by serology. Between baseline and follow-up, signs of mental and physical strain increased significantly in the sample. Symptom expectations associated with COVID-19 and a self-reported history of COVID-19, but not serologically confirmed SARS-CoV-2 infection, significantly predicted somatic symptom deterioration at follow-up. A further predictor was baseline psychological symptom burden. Conclusions: This study supports a disease-overarching biopsychosocial model for the development of burdensome somatic symptoms during the COVID-19 pandemic and supports research findings that symptom burden may be more related to the psychosocial effects of the pandemic than to infection itself. Future studies on Long COVID should include SARS-CoV-2 negative control groups and consider symptom burden prior to infection in order to avoid an overestimation of prevalence rates.

"Belly Only Pregnancy" content on social media and in internet blogs: a qualitative analysis on its definition and potential risks and benefits.

PURPOSE: Social media enlarge the impact of health and fitness trends on body image and lifestyle choices, also in birthing parents. A new and yet to investigate social media trend addressing expectant mothers is "Belly Only Pregnancy". This qualitative study sought to define this new trend and clarify whether content related to this trend might disrupt body image or eating habits in expectant mothers. METHODS: Picture and text data were gathered on a key day by screening Instagram and blog posts including or linking #bellyonlypregnancy. The identified data were categorized applying qualitative content analysis using MAXQDA software version 2018. RESULTS: Three hundred and fifty-one Instagram and eight blog posts were included. Our qualitative analysis' results indicated that the term "Belly Only Pregnancy" was used for describing: (1) The phenotype of an athletic woman whose abdominal size enlarges during pregnancy while not gaining excessive fat tissue. (2) An active lifestyle during pregnancy consisting of healthy nutrition and regular exercise pursuing goals like fast weight loss post-partum. Also, bodily, and mental gestational changes and the feasibility of this lifestyle were discussed. CONCLUSION: A "Belly Only Pregnancy" allegorizes an ideal body type for expecting mothers. Especially women with increased vulnerability for an eating disorder might be negatively affected by the consumption of content linked to this trend. However, the positive effects of a healthy diet and exercise should not be denied keeping into account the increasing prevalence of obesity and gestational diabetes. LEVEL OF EVIDENCE: Level III: Evidence obtained from cohort or case-control analytic studies.

[Attitudes Towards COVID-19 Vaccination Compared to Influenza Vaccination Among Hospital Staff]. / Einstellungen gegenüber der COVID-19-Impfung im Vergleich zur Grippeschutzimpfung bei Krankenhauspersonal.

This cross-sectional study compared hospital staff who had received influenza or COVID-19 vaccination or who had refused COVID-19 vaccination in terms of attitudes towards each vaccination, uptake of influenza vaccination and reasons for refusing COVID-19 vaccination. COVID-19 vaccine refusers rated the risk of infection for themselves and in general and the effectiveness of the vaccination lowest and the vaccination risk highest compared to the other two groups. They also reported the lowest past uptake of influenza vaccination. Perceived pressure to vaccinate proved to be a relevant barrier. Future vaccination campaigns should maintain a balance between information on vaccines, the need for vaccination, and voluntary uptake.

Somatic symptom disorder: a scoping review on the empirical evidence of a new diagnosis.

BACKGROUND: In 2013, the diagnosis of somatic symptom disorder (SSD) was introduced into the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This review aims to comprehensively synthesize contemporary evidence related to SSD. METHODS: A scoping review was conducted using PubMed, PsycINFO, and Cochrane Library. The main inclusion criteria were SSD and publication in the English language between 01/2009 and 05/2020. Systematic search terms also included subheadings for the DSM-5 text sections; i.e., diagnostic features, prevalence, development and course, risk and prognostic factors, culture, gender, suicide risk, functional consequences, differential diagnosis, and comorbidity. RESULTS: Eight hundred and eighty-two articles were identified, of which 59 full texts were included for analysis. Empirical evidence supports the reliability, validity, and clinical utility of SSD diagnostic criteria, but the further specification of the psychological SSD B-criteria criteria seems necessary. General population studies using self-report questionnaires reported mean frequencies for SSD of 12.9% [95% confidence interval (CI) 12.5-13.3%], while prevalence studies based on criterion standard interviews are lacking. SSD was associated with increased functional impairment, decreased quality of life, and high comorbidity with anxiety and depressive disorders. Relevant research gaps remain regarding developmental aspects, risk and prognostic factors, suicide risk as well as culture- and gender-associated issues. CONCLUSIONS: Strengths of the SSD diagnosis are its good reliability, validity, and clinical utility, which substantially improved on its predecessors. SSD characterizes a specific patient population that is significantly impaired both physically and psychologically. However, substantial research gaps exist, e.g., regarding SSD prevalence assessed with criterion standard diagnostic interviews.

Symptom Perceptions in Functional Disorders, Major Health Conditions, and Healthy Controls: A General Population Study.

Background: The present study investigated differences in symptom perceptions between individuals with functional disorders (FD), major health conditions, and FDs + major health conditions, respectively, and a group of healthy individuals. Furthermore, it investigated the relevance of FDs among other health-related and psychological correlates of symptom perceptions in the framework of the Common Sense Model of Self-Regulation (CMS). Method: This cross-sectional study used epidemiological data from the Danish Study of Functional Disorders part two (N = 7,459 participants, 54% female, 51.99 ± 13.4 years). Symptom perceptions were assessed using the Brief Illness Perception Questionnaire (B-IPQ) and compared between the four health condition groups. Multiple regression analyses were performed to examine associations between symptom perceptions, FDs, and other health-related and psychological correlates from the CMS framework. Results: Individuals with FDs (n = 976) and those with FDs + major health conditions (n = 162) reported less favorable symptom perceptions compared to the other two groups, particularly regarding perceived consequences, timeline, and emotional representations (effect size range Cohen's d = 0.12-0.66). The presence of a FD was significantly associated with all B-IPQ items, even in the context of 16 other relevant health-related and psychological correlates from the CMS framework, whereas symptom presence last year or last week was not. Conclusion: In the general population, symptom perceptions seem to play a more salient role in FD than in individuals with well-defined physical illness. Symptom perceptions should therefore be targeted in both primary and secondary interventions for FDs.

The development and psychometric evaluation of FABIANA-checklist: a scale to assess factors influencing treatment initiation in anorexia nervosa.

BACKGROUND: A long duration of untreated illness (DUI) is an unfavorable prognostic factor in anorexia nervosa (AN) and is associated with chronic illness progression. Although previous preventive measures aimed at reducing DUI and thus improving short- and long-term treatment outcomes have been partially successful, a better understanding of the factors involved in the sensitive phase prior to treatment initiation is needed. To date, there is no validated instrument available to assess these factors specifically for patients with AN. The FABIANA-project (Facilitators and barriers in anorexia nervosa treatment initiation) aims at identifying predictors of the DUI in order to target preventive measures better in the future. As part of this project, the FABIANA-checklist was developed, based on a multi-informant perspective and a multimodal bottom-up approach. The present study focusses on the process of item generation, item selection and psychometric validation of the checklist. METHODS: Based upon a previous qualitative study, an initial set of 73 items was generated for the most frequently mentioned facilitators and barriers of treatment initiation in AN. After a process of consensual rating and cognitive pre-testing, the resulting 25-item version of the FABIANA-checklist was provided to a sample of female patients (N = 75), aged ≥ 14 years with AN that underwent their first psychotherapeutic treatment in the last 12 months. After item analysis, dimensionality of the final version of the FABIANA-checklist was tested by Principal Component Analysis (PCA). We evaluated construct validity assuming correlations with related constructs, such as perceived social support (F-SozU), support in the health care system (PACIC-5A), illness perception and coping (BIPQ). RESULTS: We included 54 adult and 21 adolescent patients with AN, aged on average 21.4 years. Average BMI was 15.5 kg/m2, age of onset was 19.2 years and average DUI was 2.25 years. After item analysis, 7 items were excluded. The PCA of the 18-item-FABIANA-checklist yielded six components explaining 62.64% of the total variance. Overall internal consistency was acceptable (Cronbach's α = .76) and construct validity was satisfactory for 14 out of 18 items. Two consistent components emerged: "primary care perceived as supportive and competent" (23.33%) and "emotional and practical support from relatives" (9.98%). With regard to the other components, the heterogeneity of the items led to unsatisfactory internal consistency, single item loading and in part ambiguous interpretability. CONCLUSIONS: The FABIANA-checklist is a valid instrument to assess factors involved in the process of treatment initiation of patients with AN. Psychometrics and dimensionality testing suggests that experienced emotional and practical support from the primary health care system and close relatives are main components. The results indicate that a differentiated assessment at item level is appropriate. In order to quantify the relative importance of the factors and to derive recommendations on early-intervention approaches, the predictive effect of the FABIANA-items on the DUI will be determined in a subsequent study which will further include the perspective of relatives and primary caregivers. Trial registration Clinical Trials.gov Identifier: NCT03713541: https://clinicaltrials.gov/ct2/show/NCT03713541 .

Early treatment contributes to a more favorable illness course and an improved prognosis in patients with anorexia nervosa (AN). The current study presents the development of the FABIANA checklist, which aims to assess factors which influence duration of untreated illness. The FABIANA checklist was developed on the basis of interviews with patients, their relatives and primary care practitioners. It provides data from the first use of the checklist in a German sample of 75 patients with AN. The results of our study suggest that the FABIANA-checklist is a valid instrument to assess factors involved in the process of treatment initiation. Emotional and practical support from the primary health care system and close relatives were the most consistent components. A follow-up study will investigate the relationship between the FABIANA-items and the DUI in order to guide the conception of effective secondary prevention measures.

How do care providers evaluate collaboration? - qualitative process evaluation of a cluster-randomized controlled trial of collaborative and stepped care for patients with mental disorders.

BACKGROUND: Collaborative and stepped care (CSC) models are recommended for mental disorders. Their successful implementation depends on effective collaboration between involved care providers from primary and specialist care. To gain insights into the collaboration experiences of care providers in CSC against the backdrop of usual mental health care, a qualitative process evaluation was realized as part of a cluster-randomized controlled trial (COMET) of a collaborative and stepped care model in Hamburg (Germany). METHODS: Semi-structured interviews were conducted with N = 24 care providers from primary and specialist care (outpatient psychotherapists and psychiatrists, inpatient/ day clinic mental health providers) within and outside of COMET at the trial's beginning and 12 months later. Interviews were analyzed applying a qualitative structuring content analysis approach, combining deductive and inductive category development. RESULTS: Usual mental health care was considered deficient in resources, with collaboration being scarce and mainly taking place in small informal networks. Within the COMET trial, quicker referral paths were welcomed, as were quarterly COMET network meetings which provided room for exchange and fostered mutual understanding. Yet, also in COMET, collaboration remained difficult due to communication problems, the unfavorable regional distribution of the COMET care providers and interprofessional discrepancies regarding each profession's role, competencies and mutual esteem. Ideas for improvement included more localized networks, the inclusion of further professions and the overall amelioration of mental health care regarding resources and remuneration, especially for collaborative activities. CONCLUSIONS: The process evaluation of the COMET trial revealed the benefits of creating room for interprofessional encounter to foster collaborative care. Despite the benefits of faster patient referrals, the COMET network did not fulfill all care providers' prior expectations. A focus should be set on interprofessional competencies, mutual perception and role clarification, as these have been revealed as significant barriers to collaboration within CSC models such as COMET. TRIAL REGISTRATION: The COMET trial (Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers) has been registered on July 24, 2017 under the trial registration number NCT03226743 .

Helpful explanatory models for somatoform symptoms (HERMES): study protocol of a randomised mixed-methods pilot trial.

INTRODUCTION: Persistent somatic symptoms (PSS) are common both in the general population and primary care. They are bothersome in terms of psychological and somatic symptom burden. Health professionals often struggle with communication, as there is a lack of scientifically supported explanatory models for PSS or a focus merely on somatic aspects of the complaints, which both frustrate patients' needs. The objective of the present study is therefore to develop a psychoeducational intervention based on a current evidence-based explanatory model, to examine its feasibility and form the basis for a large-scale randomised controlled trial. METHODS AND ANALYSIS: In a randomised controlled mixed-methods pilot trial, 75 adult psychosomatic outpatients with PSS (duration of symptoms ≥6 months) and accompanying psychological (Somatic Symptom B-Criteria Scale total score ≥18) and somatic symptom burden (Patient Health Questionnaire-15 score >10) and no prior psychosomatic treatment will be eligible. Participants will be presented with either the explanatory model without (intervention group 1, n=25) or with elements of personalisation (intervention group 2, n=25). Participants in the control group (n=25) will receive information on current PSS guidelines. Participants will be blinded to group assignment and interventions will be shown on tablet computers at the outpatient clinic. After 1 month, qualitative follow-up telephone interviews will be conducted. As primary outcomes, mean changes in psychological and somatic symptom burden will quantitatively be compared between groups, respectively. Behavioural change mechanisms and feasibility of the three interventions will be evaluated using quantitative and qualitative measures. ETHICS AND DISSEMINATION: Ethics approval has been granted by the medical ethics board of the Hamburg Medical Chamber (PV5653). Results from this study will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: DRKS00018803.

Facilitators and barriers in anorexia nervosa treatment initiation: a qualitative study on the perspectives of patients, carers and professionals.

BACKGROUND: An early psychotherapeutic treatment of anorexia nervosa (AN) is crucial for a good prognosis. In order to improve treatment initiation, knowledge about facilitators and barriers to treatment is needed. OBJECTIVE: Against this background, we aimed to identify facilitators and barriers from the perspectives of patients, carers and professionals using a qualitative approach. METHOD: To this end, semi-structured interviews were conducted in triads of female patients with AN aged 14 years and older at the beginning of their first psychotherapeutic treatment, their carers, and referring health care professionals. A modified Grounded Theory approach was used for analysis. RESULTS: In total, 22 interviews were conducted (n = 6 adults, n = 4 adolescents, 4 full triads). The duration of untreated AN ranged between 30 days and 25.85 years (M = 3.06 ± 8.01 years). A wide spectrum of facilitators and barriers within the patient, the social environment, the health care system and the society were identified. Most prominent factors were 'recognizing and addressing' by close others, 'waiting times and availability' and 'recommendations and referrals' by health care professionals. 'Positive role models for treatment' were perceived as a specific facilitative social influence. Facilitators were more frequently mentioned than barriers and most of the factors seem to hold potential for modifiability. CONCLUSION: Overall, the findings suggest that early intervention approaches for AN should not only address patients and the health care system, but may also involve carers and successfully treated former patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03713541 .

Psychotherapists' perspective on the treatment of patients with somatic symptom disorders.

OBJECTIVE: Guidelines recommend psychotherapy in addition to primary care for patients with moderate to severe somatic symptom disorders. While general practitioners' experiences have been well studied, psychotherapists' experiences with this patient group and the explanatory models psychotherapists use in psychotherapy are unknown. METHODS: Semi-structured qualitative interviews were conducted between April and July 2018 with 20 German licensed outpatient psychotherapists with either a medical or a psychological background, using the label "somatoform disorders". Interviews were analyzed applying thematic analysis. RESULTS: Psychotherapists experienced management of affected patients as challenging and partly frustrating, mainly due to the difficult diagnostic process and the "somatic fixation" of some patients. Diagnostic labelling was considered a delicate issue, with some psychotherapists using the term "somatoform", while others preferred either "functional" or vague descriptions like "psychosomatic". The explanatory process was deemed essential for treatment, as was the adaptation of explanations to both a patient's biography and language. As main explanatory factors, psychotherapists referred to generic vulnerability factors, previous somatic illness and health care system influences. CONCLUSIONS: Explanatory models used in psychotherapy are patient-centred, processual and constitute a major component of the psychotherapeutic process. However, this process might be impeded if patients are confronted with different diagnostic labels and explanatory models during their pathways through care.

Psychotherapists' perspectives on collaboration and stepped care in outpatient psychotherapy-A qualitative study.

OBJECTIVE: Stepped and collaborative care with outpatient psychotherapy as one treatment step is guideline-recommended for mental health care. To date, the experiences and evaluation of psychotherapists regarding collaboration and stepped care have been neglected. In order to improve collaborative mental health care, this qualitative study aimed at identifying psychotherapists' perspectives and needs within collaboration and stepped care. METHODS: Semi-structured qualitative interviews with 20 German outpatient psychotherapists were conducted and analyzed applying thematic analysis. The analysis was realized in a recursive process to first identify themes and then relate these themes back to the research questions with regard to collaboration and stepped care. RESULTS: Collaboration mainly took place in small networks, with general practitioners and psychiatrists as the most important partners and psychotherapists wishing to intensify collaboration. Main barriers for collaboration were seen in deficient resources and remuneration and in a perceived lack of esteem by other medical specialties. Stepped care was appreciated for intensified collaboration and low-threshold access to care. Doubts were cast on its implementation within current health care conditions, worries concerned a primacy of economic principles instead of patient-orientation. Among further needs, psychotherapists demanded increased knowledge about psychotherapy, especially among general practitioners. CONCLUSION: Psychotherapists expressed ambivalent attitudes towards stepped and collaborative care, substantially influenced by health care conditions and the perceived own standing among care providers. Psychotherapists' needs within stepped care comprise intensified collaboration, sufficient time, personal and financial resources for collaboration and opportunities for a constructive interprofessional dialogue.