KCE-17003: Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy versus Face-to-Face Psychotherapy for Depression: A pragmatic multicentre randomized controlled non-inferiority trial - BLENDED
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.
| 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 |
|
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 |
9 Centres for Mental Health (CGGs) in Flanders |
| Protocol | download here |
| Report |
Q1 2021 first report Q3 2023 longterm follow-up |
| Publication |
Q1 2021 main publication Q3 2023 longterm follow-up |
