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| Name | Class |
|---|---|
| Heinrich-Heine University, Duesseldorf | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mental health specialist video consultation | Experimental | 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. |
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| treatment as usual by the GP | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mental health specialist video consultation | Behavioral | 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Negative Effects of Psychotherapy (INEP) | unintended/adverse effects of the intervention | 6 months after inclusion, 12 months after inclusion (not measured at baseline, patients in control condition fill in adapted version) |
| Normalisation MeAsure Development questionnaire (NoMAD) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus W Haun, MD, MSc | Department of General Internal Medicine and Psychosomatics, Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg University | Heidelberg | Baden-Wurttemberg | D-69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41680544 | Derived | Muller S, Gagelmann L, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Primary Care Physicians' Experiences with Integrated Mental Health Specialist Video Consultations-A Normalization Process Theory-Based Mixed-Methods Evaluation. J Gen Intern Med. 2026 Feb 12. doi: 10.1007/s11606-025-10109-4. Online ahead of print. | |
| 41199204 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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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 |
measurement of acceptance of newly introduced treatment models, 4 dimensions, range:1-5, lower score indicates greater acceptance of the intervention |
| 6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only) |
| Muller S, Ritter-von Kramer A, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Engaging underrepresented patient groups in specialised treatment - qualitative results from the PROVIDE-C randomised trial on integrated mental health video consultations for depression and anxiety. BMC Public Health. 2025 Nov 6;25(1):3817. doi: 10.1186/s12889-025-25235-1. |
| 40939424 | Derived | van Eickels D, Henning K, Wensing M, Friederich HC, Haun MW. Psychometric validation of the German version of the somatic symptom disorder - B criteria scale (SSD-12) in a primary care population with depression and anxiety: A COSMIN-guided analysis. Gen Hosp Psychiatry. 2025 Nov-Dec;97:3-10. doi: 10.1016/j.genhosppsych.2025.09.001. Epub 2025 Sep 4. |
| 39322237 | Derived | Haun MW, Tonnies J, Hartmann M, Wildenauer A, Wensing M, Szecsenyi J, Feisst M, Pohl M, Vomhof M, Icks A, Friederich HC. Model of integrated mental health video consultations for people with depression or anxiety in primary care (PROVIDE-C): assessor masked, multicentre, randomised controlled trial. BMJ. 2024 Sep 25;386:e079921. doi: 10.1136/bmj-2024-079921. |
| 33952313 | Derived | Haun MW, Tonnies J, Krisam R, Kronsteiner D, Wensing M, Szecsenyi J, Vomhof M, Icks A, Wild B, Hartmann M, Friederich HC. Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial). Trials. 2021 May 5;22(1):327. doi: 10.1186/s13063-021-05289-3. |