NCT02542891

Brief Summary

To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU). Within the French context the TAU is considered as the traditional face to face CBT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

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

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

April 27, 2026

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

September 4, 2015

Last Update Submit

April 22, 2026

Conditions

Depressive Disorder

Keywords

e-healthdepressive disordercost-effectivenessCognitive behavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    The primary outcome measure is symptoms of depression as assessed with Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. The 9 items are each scored on a 0-3 scale with the total score ranging from 0-27 and higher scores indicating more severe depression. The PHQ-9 has shown to have good psychometric properties (Wittkampf, Naeije, Schene, Huyser, \& van Weert, 2007).

    12 months

Secondary Outcomes (3)

  • QIDS-SR16

    12 months

  • M.I.N.I

    12 months

  • MADRS

    12 months

Other Outcomes (3)

  • EQ-5D-5L

    12 months

  • AQOL-6D

    12 months

  • TIC-P

    12 months

Study Arms (2)

Blended CBT

EXPERIMENTAL

Internet based blended depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with smart phone components. The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. These will be delivered over 16 sessions (8 online and 8 face-to-face), once a week. The online platform is called Moodbuster. The trial will not interfere with regular medication treatment, and patient's care will be monitored throughout the study.

Other: Blended CBT

Treament as Usual (TAU)

ACTIVE COMPARATOR

In order to increase the comparability between the two arms, we defined TAU as a traditional face to face CBT of 16 sessions. These sessions will be administered over a course of 16 weeks. The trial will not interfere with regular medication treatment, and patient's care will be monitored throughout the study.

Other: Treatment as Usual (TAU)

Interventions

Blended CBTOTHER
Also known as: Moodbuster Platform
Blended CBT
Treatment as Usual (TAU)OTHER
Treament as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older
  • Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
  • Having a PHQ-9 score greater than 5
  • Having access to a PC and Internet connection
  • Having ( or accepting to be loaned) a smartphone that is compatible with the mobile component of the intervention
  • Understanding of the French language spoken and written

You may not qualify if:

  • Current high risk for suicide according to the MINI Interview section C
  • Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, and suicide risks, as established at the MINI interview
  • Currently receiving psychological treatment for depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

Location

CHU de Brest

Brest, France

Location

Centre Hospitalier Le Vinatier-

Bron, 69678, France

Location

CHU de Clermont- Ferrnand

Clermont-Ferrand, 63003, France

Location

Hôpital A. Chenevier

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, France

Location

Hôpital de la conception Pôle Psychiatrie Centre

Marseille, 13005, France

Location

CHRU Lapeyronie

Montpellier, 34295, France

Location

Hôptial Fernand Widal

Paris, 75010, France

Location

CHU de Tours

Tours, 37540, France

Location

Related Publications (3)

  • Doukani A, Quartagno M, Sera F, Free C, Kakuma R, Riper H, Kleiboer A, Cerga-Pashoja A, van Schaik A, Botella C, Berger T, Chevreul K, Matynia M, Krieger T, Hazo JB, Draisma S, Titzler I, Topooco N, Mathiasen K, Vernmark K, Urech A, Maj A, Andersson G, Berking M, Banos RM, Araya R. Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial. J Med Internet Res. 2024 May 31;26:e47515. doi: 10.2196/47515.

    PMID: 38819882DERIVED

  • van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.

    PMID: 34874888DERIVED

  • Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.

    PMID: 27488181DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Karine Chevreul, Dr

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

October 31, 2016

Study Completion

September 15, 2018

Last Updated

April 27, 2026

Record last verified: 2016-12

Locations

FR(10)