Back to results

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

Primary Purpose

Depression, Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

mental health specialist video consultation

About this trial

This is an interventional health services research trial for Depression focused on measuring primary care, mental health, telemedicine, video consultations, effectiveness, health services research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

Heidelberg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mental health specialist video consultation

treatment as usual by the GP

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

The Patient Health Questionnaire (PHQ-9)

depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)

Generalized Anxiety Disorder Scale (GAD-7)

anxiety symptom severity, range: 0-21, higher score indicates worse outcome

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

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

Somatic Symptom Disorder-B Criteria Scale (SSD-12)

self-reported somatisation, range: 0-48, higher score indicates worse outcome

Patient Assessment of Chronic Illness Care (PACIC)

patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction

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

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

Full Information

NCT ID

NCT04316572

First Posted

March 18, 2020

Last Updated

July 30, 2023

Sponsor

Heidelberg University

Collaborators

Heinrich-Heine University, Duesseldorf

1. Study Identification

Unique Protocol Identification Number

NCT04316572

Brief Title

Mental Health Specialist Video Consultations for Primary Care Patients

Acronym

PROVIDE-C

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 24, 2020 (Actual)

Primary Completion Date

May 24, 2022 (Actual)

Study Completion Date

November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

Collaborators

Heinrich-Heine University, Duesseldorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety Disorder

Keywords

primary care, mental health, telemedicine, video consultations, effectiveness, health services research

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

376 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mental health specialist video consultation

Arm Type

Experimental

Arm Description

Arm Title

treatment as usual by the GP

Arm Type

No Intervention

Arm Description

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).

Intervention Type

Behavioral

Intervention Name(s)

mental health specialist video consultation

Intervention Description

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

Primary Outcome Measure Information:

Title

The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)

Description

composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)

Time Frame

6 months after inclusion

Secondary Outcome Measure Information:

Title

The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)

Description

composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)

Time Frame

12 months after inclusion

Title

The Patient Health Questionnaire (PHQ-9)

Description

depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)

Time Frame