Clinical trial NCT02542891: European Comparative Effectiveness Research on Internet-based Depression Treatment
Official title: E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: e-health
depressive disorder
cost-effectiveness
Cognitive behavioral treatment
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
name: Fondation FondaMental
name: Assistance Publique - Hôpitaux de Paris
First posted: 2015-09-07
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
Secondary outcomes:
measure: QIDS-SR16
timeFrame: 12 months
measure: M.I.N.I
timeFrame: 12 months
measure: MADRS
timeFrame: 12 months
Other outcomes:
measure: EQ-5D-5L
timeFrame: 12 months
measure: AQOL-6D
timeFrame: 12 months
measure: TIC-P
timeFrame: 12 months
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: Brest
country: France
facility: CHU de Brest
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier-
city: Clermont- Ferrand
country: France
facility: CHU de Clermont- Ferrnand
city: Creteil
country: France
facility: Hôpital A. Chenevier
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille
country: France
facility: Hôpital de la conception Pôle Psychiatrie Centre
city: Montpellier
country: France
facility: CHRU Lapeyronie
city: Paris
country: France
facility: Hôptial Fernand Widal
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Karine Chevreul, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.