NCT04316572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 24, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

March 18, 2020

Last Update Submit

July 30, 2023

Conditions

DepressionAnxiety Disorder

Keywords

primary caremental healthtelemedicinevideo consultationseffectivenesshealth services research

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

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

    12 months after inclusion

  • The Patient Health Questionnaire (PHQ-9)

    6 months after inclusion, 12 months after inclusion

  • Generalized Anxiety Disorder Scale (GAD-7)

    6 months after inclusion, 12 months after inclusion

  • Short-Form Health Survey 12 (SF-12)

    6 months after inclusion, 12 months after inclusion

  • Recovery Assessment Scale (RAS-G)

    6 months after inclusion, 12 months after inclusion

  • +4 more secondary outcomes

Other Outcomes (2)

  • 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)

  • Normalisation MeAsure Development questionnaire (NoMAD)

    6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only)

Study Arms (2)

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.

Behavioral: mental health specialist video consultation

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).

Interventions

mental health specialist video consultationBEHAVIORAL

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

mental health specialist video consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg University

Heidelberg, Baden-Wurttemberg, D-69120, Germany

Location

Related Publications (4)

  • 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.

    PMID: 41199204DERIVED

  • 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.

    PMID: 40939424DERIVED

  • 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.

    PMID: 39322237DERIVED

  • 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.

    PMID: 33952313DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Markus W Haun, MD, MSc

    Department of General Internal Medicine and Psychosomatics, Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Specialist and Head of the Junior Research Group PROVIDE

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

March 24, 2020

Primary Completion

May 24, 2022

Study Completion

November 18, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

DE(1)