PROVIDE-C: Mental Health Specialist Video Consultations for Primary Care Patients

Sponsor

Heidelberg University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04316572

Collaborator

Heinrich-Heine University, Duesseldorf (Other)

320

Enrollment

Location

Arms

31.3

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Disorder	Behavioral: mental health specialist video consultation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 24, 2020

Anticipated Primary Completion Date :

May 3, 2022

Anticipated Study Completion Date :

Nov 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mental health specialist video consultation 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 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
No Intervention: treatment as usual by the GP 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).

Arm

Intervention/Treatment

Experimental: mental health specialist video consultation

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

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

No Intervention: treatment as usual by the GP

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS) [12 months after inclusion]
composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)
The Patient Health Questionnaire (PHQ-9) [6 months after inclusion, 12 months after inclusion]
depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)
Generalized Anxiety Disorder Scale (GAD-7) [6 months after inclusion, 12 months after inclusion]
anxiety symptom severity, range: 0-21, higher score indicates worse outcome
Short-Form Health Survey 12 (SF-12) [6 months after inclusion, 12 months after inclusion]
health related quality of life (two dimensions: physical and mental quality of life, ranges: 0-100, higher score indicates higher quality of life
Recovery Assessment Scale (RAS-G) [6 months after inclusion, 12 months after inclusion]
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
Somatic Symptom Disorder-B Criteria Scale (SSD-12) [6 months after inclusion, 12 months after inclusion]
self-reported somatisation, range: 0-48, higher score indicates worse outcome
Patient Assessment of Chronic Illness Care (PACIC) [6 months after inclusion, 12 months after inclusion]
patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction
EQ-5D [6 months after inclusion, 12 months after inclusion]
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
Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy) [6 months after inclusion, 12 months after inclusion]
self reported use of medical and psychosocial services for health-economic evaluation

Other Outcome Measures

Assessment of Negative Effects of Psychotherapy (INEP) [6 months after inclusion, 12 months after inclusion (not measured at baseline, patients in control condition fill in adapted version)]
unintended/adverse effects of the intervention
Normalisation MeAsure Development questionnaire (NoMAD) [6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only)]
measurement of acceptance of newly introduced treatment models, 4 dimensions, range:1-5, lower score indicates greater acceptance of the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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