Abstract
BackgroundMost people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care.MethodsIn an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation.DiscussionTo the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany.Trial registrationClinicalTrials.gov, United States National Institutes of Health NCT04316572. Prospectively registered on 20 March 2020.
Highlights
Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP)
The PROVIDE-C randomised controlled trial (RCT) aims to evaluate whether Mental health specialist video consultation (MHSVC) integrated into primary care is a clinically effective and economically efficient treatment in patients presenting with depression and anxiety in comparison to usual care
Discussion an array of effective treatments is available, depression and anxiety disorders still cause a notable burden to many people worldwide
Summary
Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP) [4, 10, 11] While this can be highly effective and some patients prefer to be treated by their own GP, as their GP witness their medical history providing truly personalised health care [12], a significant number of patients suffering from mental health conditions, those with somatic comorbidity, are not recognised, do not receive adequate treatment, or need specialised mental health care [13,14,15]. While most GPs commit themselves to comprehensive care of both medical diseases and psychosocial distress, due to the “somatisation effect” in doctor-patient interaction in primary care, they may emphasise the assessment and treatment of somatic symptoms [16, 17]
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