Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02542891
Study type Interventional
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact
Status Completed
Phase N/A
Start date September 2015
Completion date September 15, 2018

See also
  Status Clinical Trial Phase
Completed NCT01316926 - Paxil CR Bioequivalence Study Brazil Phase 1
Recruiting NCT06187454 - Transcranial Direct Current Stimulation for Depression N/A
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05768126 - Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine Phase 4
Completed NCT03219879 - Telephone-administered Relapse Prevention for Depression N/A
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT03043560 - Study to Treat Major Depressive Disorder With a New Medication Phase 2
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT00069459 - Seasonal Affective Depression (SAD) Study Phase 1
Recruiting NCT05503966 - Combining Antidepressants and Attention Bias Modification in Depression N/A
Recruiting NCT03001245 - Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents N/A
Completed NCT02939560 - TMS for Adults With Autism and Depression N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Withdrawn NCT02238730 - Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy N/A
Completed NCT02306551 - Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT01597661 - Bupropion & Cardio Birth Defect (Slone) N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A
Completed NCT01829100 - Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression N/A