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.

Understanding illness experiences of patients with primary sclerosing cholangitis: a qualitative analysis within the SOMA.LIV study.

BACKGROUND: Primary sclerosing cholangitis (PSC) is a rare cholestatic liver disease with a largely unpredictable course. Due to limited treatment options, individuals may for many years suffer from distressing symptoms and the emotional burden of an uncertain future. The need to shift from cure to care of PSC has spurred an interest into patients' health-related quality of life. Qualitative research in this context remains scarce. Hence, this study aimed to enrich the clinical understanding about the lived experience of PSC through a qualitative approach. METHODS: A total of 20 patients with PSC were recruited at a specialist centre for autoimmune liver disease in Germany and engaged in semi-structured telephone-based interviews between March and June 2022. Verbatim transcripts were interpreted using inductive thematic analysis. RESULTS: An overarching concept of 'a wave-like experience' was formulated to illustrate the dual and shifting nature of living with PSC. Reflecting upon this central idea, three major themes were generated to address important aspects of participants' illness experiences: 'Invisible presence' focused on perceptions of suffering from a seemingly hidden illness that periodically reveals itself through specific trigger events. 'Embracing the threat' captured the psycho-emotional response shift to this chronic disease from a predominantly negative to a coping-oriented pattern with regular setbacks. 'Between control and constraints' uncovered restrictions that PSC enforces onto patients' lives and their desire for controllability. CONCLUSIONS: The present study provides an in-depth look at the fluctuating tensions arising from a life with PSC. Insights on perceived invisibility, disease-related triggers of emotional distress and the complexity behind self-management highlight opportunities for enhanced clinical support of this patient group.

Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT).

INTRODUCTION: Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. METHODS AND ANALYSIS: To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies. TRIAL REGISTRATION NUMBER: ISRCTN30800023.

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 .

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.

Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

INTRODUCTION: Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual. METHODS AND ANALYSIS: In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare. TRIAL REGISTRATION NUMBER: NCT03226743.

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research]. / Erprobung eines integrierten und gestuften Behandlungsmodells für psychische Störungen und Komorbiditäten im Hamburger Netzwerk für Versorgungsforschung.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

Management of comorbid mental and somatic disorders in stepped care approaches in primary care: a systematic review.

Background: Stepped care models comprise a graded treatment intensity and a systematic monitoring. For an effective implementation, stepped care models have to account for the high rates of mental and somatic comorbidity in primary care. Objectives: The aim of the systematic review was to take stock of whether present stepped care models take comorbidities into consideration. A further aim was to give an overview on treatment components and involved health care professionals. Methods: A systematic literature search was performed using the databases PubMed, PsycINFO, Cochrane Library and Web of Science. Selection criteria were a randomized controlled trial of a primary-care-based stepped care intervention, adult samples, publication between 2000 and 2017 and English or German language. Results: Of 1009 search results, 39 studies were eligible. One-third of the trials were conceived for depressive disorders only, one-third for depression and further somatic and/or mental comorbidity and one-third for conditions other than depression. In 39% of the studies comorbidities were explicitly integrated in treatment, mainly via transdiagnostic self-management support, interprofessional collaboration and digital approaches for treatment, monitoring and communication. Most care teams were composed of a primary care physician, a care manager and a psychiatrist and/or psychologist. Due to the heterogeneity of the addressed disorders, no meta-analysis was performed. Conclusions: Several stepped care models in primary care already account for comorbidities, with depression being the predominant target disorder. To determine their efficacy, the identified strategies to account for comorbidities should be investigated within stepped care models for a broader range of disorders.