European Comparative Effectiveness Research on Internet-based Depression Treatment
European Comparative Effectiveness Research on Internet-based Depression Treatment
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.
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).
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