Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy versus Face-to-Face Psychotherapy for Depression: A pragmatic multicentre randomized controlled non-inferiority trial (KCE-17003)

Summary (Dutch or French)

Depression is a severe mental disorder that affects 5-7% of Belgians each year. Unfortunately, many individuals with depression do not seek professional help, and if they do seek professional help, waiting lists for psychotherapy are typically very long.

To help resolve this problem, this study aims to investigate whether blended therapies, i.e. therapies that consist of a mixture of face-to-face sessions and online sessions, are (cost-)effective as a treatment for depression, and whether they are as (cost-)effective as traditional treatments which consist of face-to-face sessions alone. Should this be the case, then blended therapy can be implemented on a large scale in mental health care, as it could provide a more cost-effective means of helping individuals with depression.

This study also aims to investigate whether certain patient features, such as the severity of depression and personality traits, may influence the efficacy of (blended) psychotherapy for depression.

Finally, we will also investigate patients‟ attitudes towards and experience of blended therapy.

Trial Description
Title

Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy versus Face-to-Face Psychotherapy for Depression: A pragmatic multicentre randomized controlled non-inferiority trial- KCE-17003

Participants (P)

Patients with major depressive disorder treated in Centres for Mental Health (CGGs)

Intervention (I)

Blended care psychodynamic or cognitive behavioral therapy, consisting of 8 face-to-face sessions and 8 modules that have to be completed online between face-to-face sessions.

Control (C)

Face-to-face psychotherapy (i.e., 16 weekly sessions of psychodynamic or cognitive behavioral therapy).

Outcome (O)

The primary endpoint is the BDI-II score at 6 months follow up

Trial Design

Multicentre randomised open label non-inferiority Phase III trial

Sample Size

504 patients

Trial duration

24 months first report. 42 months longterm follow-up report.

Budget

€2,500,000 (incl. VAT)

Status

Open

 

Trial team

Sponsor

UZ Leuven - KU Leuven

Chief Investigator

Prof Dr Patrick Luyten

Research Group Clinical Psychology, Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Postbus 3722, 3000 Leuven, België

and Research Department of Clinical, Educational and Health Psychology, University College London, UK

 

Trial coordinator

Dr. Eileen Tang

Clinical Psychology Research Group, Faculty of Psychology and Educational Sciences, KU Leuven

Participating centres

11 Centres for Mental Health (CGGs) in Flanders

Documents
Protocol  
Report

Q1 2021 first report

Q3 2023 longterm follow-up

Publication

Q1 2021 main publication

Q3 2023 longterm follow-up

References

Clinicaltrials.gov:

Webpage: 

Funding scheme

Investigator-led workstream 2017