An integrated mental health video consultations model for patients with somatic symptom disorder in primary care: The randomized VISION pilot trial.

OBJECTIVE: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care. METHODS: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety. RESULTS: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group. CONCLUSION: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice. TRIAL REGISTRATION: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de).

[Integrated Care for Patients with Somatic Symptom Disorder in Primary Care - A Qualitative Participatory Evaluation of a Randomised Feasibility Trial]. / Integrierte Behandlung von Patient*innen mit somatischer Belastungsstörung in Hausarztpraxen ­ Eine qualitative, patient*innenbeteiligende Evaluation einer randomisierten Machbarkeitsstudie.

OBJECTIVE: The VISION intervention is a manualized short-term treatment for people with somatic symptom disorder, integrated into the primary care and delivered by psychotherapists via video consultations. As an innovative technology-based approach, the intervention was most recently piloted in a randomized feasibility trial. During the qualitative accompanying study presented here, the intervention was evaluated and optimised from the user perspective of patients who participated in the feasibility study. METHODS: We interviewed a total of N=10 patients included in the intervention group in three semi structured focus group discussions focusing on how they (1) assess the intervention in terms of acceptance and individual benefit and (2) which adjustments are necessary from the user perspective for further optimization of the intervention. We performed a qualitative content analysis using MAXQDA Plus 2022. RESULTS: Respondents reported initial reservations on their part regarding care via video consultation. After a brief period of habituation, the intervention was universally accepted. Main suggestions for improvement included a stronger focus on supporting patients find follow-up psychotherapy (if indicated) more flexible settings (e. g., location of video consultation), and a stronger integration of treatment into primary care. DISCUSSION AND CONCLUSION: The study provides systematically elaborated comprehensive findings on participants' practical experiences with the intervention. The model is appropriate for treating people with somatic symptom disorder. Before implementation, important suggestions for improvement should be thoroughly considered with continued patient and public involvement.

Mental health specialist video consultations for patients with somatic symptom disorder in primary care: protocol for a randomised feasibility trial (the VISION trial).

INTRODUCTION: General practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices. METHODS AND ANALYSIS: Fifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters. ETHICS AND DISSEMINATION: This trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial. TRIAL REGISTRATION NUMBER: DRKS00026075.