KCE-17003: Vergleich von kombinierten Face-to-Face- + Online- vs. Face-to-Face-Therapien allein für die psychodynamische oder kognitiv-verhaltenstherapeutische Behandlung von Patienten, die an Depressionen leiden: eine pragmatische, multizentrische, rando

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

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 to recruitment

 

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

9 Centres for Mental Health (CGGs) in Flanders

DOKUMENTE
Protocol download here
Report

Q1 2021 first report

Q3 2023 longterm follow-up

Publication

Q1 2021 main publication

Q3 2023 longterm follow-up

REFERENZEN

Clinicaltrials.gov: NCT04337242

Webpage: https://ppw.kuleuven.be/blendedstudie/

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017