European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED)

E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Other: Blended CBT; Other: Treatment as Usual (TAU)

Detailed Description

Background:

Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.

Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care. The trials will be conducted in 8 European countries.

Objective:

To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatments as usual (TAU)-face to face CBT in expert centres specialized in depression.

Study design:

The study is a two-arm randomized controlled non-inferiority and cost-effectiveness trial. The trial will be conducted in expert centres in France. A total of 150 patients with MDD will be assigned to one of two treatment arms: 1) blended CBT, 2) TAU. Respondents in both arms will be followed until 12 months after baseline (measures will be taken at baseline, 3 months, post- treatment (17 weeks), 6 months and 12 months).

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Centre Hospitalier Charles Perrens
  • Brest, France
    • CHU de Brest
  • Bron, France, 69678
    • Centre Hospitalier Le Vinatier-
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont- Ferrnand
  • Créteil, France, 94010
    • Hôpital A. Chenevier
  • Grenoble, France
    • CHU de Grenoble
  • Marseille, France, 13005
    • Hôpital de la conception Pôle Psychiatrie Centre
  • Montpellier, France, 34295
    • CHRU Lapeyronie
  • Paris, France, 75010
    • Hôptial Fernand Widal
  • Tours, France, 37540
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blended CBT; 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; Other Names: Moodbuster Platform
Active Comparator: Treament as Usual (TAU); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
QIDS-SR16	The 16 item self-report version of the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation (Rush et al., 2003) is used in addition to the PHQ-9 because it is a promising questionnaire for assessing depressive symptoms especially in specialized mental health care whereas the PHQ-9 is developed for use in primary care.The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity. The QIDS is available in both clinician-rated (IDS-C) and patient self-report (IDS-SR) forms. The QIDS consists of 16 items (each item scores 0-3) and includes symptom domains of MDD based on DSM-IV and Research Diagnostic Criteria (RDC).	12 months
M.I.N.I	The full M.I.N.I. 5.0,with exception of section M (Anorexia Nervosa), N (Bulimia nervosa), and P (Antisocial personality disorder), will be assessed at baseline to assess lifetime and current depression, and current comorbid disorders that often co-occur with and predict the onset of depression (anxiety disorders and PTSD) and other comorbid disorders that are an exclusion criteria in this study (i.e. substance dependence, bipolar affective disorder, psychotic illness, and obsessive compulsive disorder). At 12 months follow-up, the depression, anxiety and PTSD sections will be assessed again.	12 months
MADRS	The MADRS (Montgomery and Asberg Depression Rating Scale) is a hetero-assessment of depressive symptoms evaluated by clinicians.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	Quality of life will be assessed with the EQ-5D-5L (EuroQol).The EQ-5D-5L is a self-report questionnaire which measures health related quality of life and enables conversion to utility scores to calculate Quality-Adjusted Life-Years (QALYs). The EQ-5D-5L consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. Each item consists of five categories ranging from no problems to a lot of problems (Van Agt, Essink-Bot, Krabbe, & Bonsel, 1994).	12 months
AQOL-6D	Health-Related Quality of Life will optionally be measured with the Assessment of Quality of Life instrument (AQoL) (Hawthorne, Richardson, & Osborne, 1999). For the current study the AQoL-6D (Richardson, Peacock, Hawthorne, Lezzi, Elsworth, & Day, 2012) which consists of 20 questions measured on a 5 point scale will be used. The AQoL-6D includes the six dimensions: independent living, mental health, coping, relationships, pain, and senses.	12 months
TIC-P	Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002). The TiC-P is a self-report questionnaire and consists of two different parts that can be administrated separately. Part I will be used to assess the participants' healthcare utilization and medication use. Part II (short form health and labor questionnaire [SF-HLQ]) measures lost productivity costs resulting from absenteeism (being absent from work because of illness) and presenteeism (being present at work while ill which may lead to reduced efficiency) and consists of 11 items. Healthcare utilization and productivity losses will be valued using country-specific prices.	12 months

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Assistance Publique - Hôpitaux de Paris; European Commission; Fondation FondaMental
• Investigators: Study Director: Karine Chevreul, Dr, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimated): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: cost-effectiveness; e-health; depressive disorder; Cognitive behavioral treatment
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Therapeutics
• Other Study ID Numbers: C15-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No