Mental Health Specialist Video Consultations for Primary Care Patients

Study Overview
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Brief Summary
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Even in Western health care systems, most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for specialists, (b) long travel distances to specialists, particularly in rural and remote areas, (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 measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In an individually randomized, prospective, two-arm superiority study with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in GP practices.

Detailed Description
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The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In total, the investigators plan to enrol 320 patients who will be randomly allocated to the experimental condition (mental health specialist video consultations) or the control condition (treatment as usual from their GP) in a 1:1 ratio. General practitioners will recruit patients during their regular clinic hours. If the patient is interested in participation, the patient will receive the informed consent form and the baseline questionnaire from the GP. The practice team will send the patient's contact details to the study team who will screen the patient with respect to the eligibility criteria. Patients will be randomly allocated to one of the two study conditions (video consultation model vs. treatment-as-usual, TAU) in a 1:1 ratio by central randomisation. The evaluation of the primary outcome will be performed according to the intention-to-treat principle. The health economic evaluation will be carried out from the perspective of society. A cost-effectiveness and a cost-utility analysis will be carried out.

Official Title
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ImPROving Cross-sectoral Collaboration Between Primary and Psychosocial Care: A Randomised Controlled Superiority Trial to Compare the Effectiveness of a Mental Health Specialist VIDEo Consultations Model Versus Treatment as Usual in Patients With Depression or Anxiety Disorders in Primary Care

Conditions
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Depression, Anxiety Disorder

Intervention / Treatment
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* Behavioral: mental health specialist video consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one of the following psychological conditions i) at least moderately severe depression, defined as a PHQ-9 score of 10 or greater with either item one and/or two being endorsed, ii) at least moderately general anxiety disorder, defined as a Generalized Anxiety Disorder (GAD)-7 score of 10 or greater, or iii) exceeding the cut off of 11 points of the combined anxiety and depression score (PHQ-ADS) currently no or as yet insufficient treatment (psychotherapy, psychopharmacotherapy, or both) or difficulty with adherence capable of giving consent written informed consent Exclusion Criteria: substance abuse/dependence that is likely to compromise intervention adherence risk of endangerment to others and/or risk of self-endangerment need for emergency medical treatment acute psychotic symptoms severe cognitive impairment or dementia significant hearing and/or visual impairment pregnancy in the ≥ 2nd Trimester prior experience with video consultations as part of the feasibility trial insufficient German language proficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mental health specialist video consultation<br>The intervention group will receive five video consultations with psychotherapists directly in the GP's practice. The consultations will be carried out via the web portal of a certified video service provider (arztkonsultation ak GmbH). The patient will be located in the GP's practice and the psychotherapist in his practice or another suitable room. Patients are scheduled for five sessions of 50 minutes. | Behavioral: mental health specialist video consultation<br>* The consultations will be based on a psychodynamic understanding with a solution-oriented stance and will follow a manual: Session 1: Getting familiar with the telemental health setting, building a working alliance and deepening diagnostics. Session 2: Clarification of the task/objective, focus building, motivational interviewing if necessary. Session 3-4: Focused brief interventions e.g. psychoeducation, promotion of social resources, activation of health-promoting lifestyles (sleep hygiene, eating diary, relaxation etc.), work on personal problems and, if necessary, initiation of further specialised treatment. Session 5: Ending the intervention, stabilisation, subsequent treatment plan and communicating a case summary to the general practitioner<br>|
| No Intervention: treatment as usual by the GP<br>Routine treatment by the GP, which may or may not include conversations about psychosocial problems and/or referral to specialised services (e.g., inpatient therapy, counseling, self-help). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS) | composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious) | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS) | composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious) | 12 months after inclusion | 
| The Patient Health Questionnaire (PHQ-9) | depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed) | 6 months after inclusion, 12 months after inclusion | 
| Generalized Anxiety Disorder Scale (GAD-7) | anxiety symptom severity, range: 0-21, higher score indicates worse outcome | 6 months after inclusion, 12 months after inclusion | 
| Short-Form Health Survey 12 (SF-12) | health related quality of life (two dimensions: physical and mental quality of life, ranges: 0-100, higher score indicates higher quality of life | 6 months after inclusion, 12 months after inclusion | 
| Recovery Assessment Scale (RAS-G) | self-reported mental health recovery, five dimension: 1) Goal and success orientation, 2) No domination by Symptoms, 3) Personal confidence and hope, 4) Reliance on others, 5) Willingness to ask others for help, ranges 1-5, higher score indicates better outcome | 6 months after inclusion, 12 months after inclusion | 
| Somatic Symptom Disorder-B Criteria Scale (SSD-12) | self-reported somatisation, range: 0-48, higher score indicates worse outcome | 6 months after inclusion, 12 months after inclusion | 
| Patient Assessment of Chronic Illness Care (PACIC) | patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction | 6 months after inclusion, 12 months after inclusion | 
| EQ-5D | health related quality of life for health economic Evaluations, 5 dimensions: 1) Mobility, 2) Self-Care, 3) Usual Activities, 4) Pain/Discomfort, 5)Anxiety/Depression | 6 months after inclusion, 12 months after inclusion | 
| Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy) | self reported use of medical and psychosocial services for health-economic evaluation | 6 months after inclusion, 12 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary care, mental health, telemedicine, video consultations, effectiveness, health services research