Effectiveness of the First French Psychoeducational Program on Unipolar Depression (PURE)
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|ClinicalTrials.gov Identifier: NCT02501226|
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : March 31, 2020
Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85% of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Inded psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France.
Methods/Design: The investigators propose to evaluate the first French psychoeducational program for depression named "ENVIE" in a multicenter randomized controlled trial. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (< 2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N=166) or to a waiting list (N=166). The follow-up will last 15 months and include 5 assessment visits (enrollment, 3, 6, 9, 12, 15 months).
Discussion. If the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression.
|Condition or disease||Intervention/treatment||Phase|
|Unipolar Depressed Outpatients Mild Severity Without Psychotic Features||Other: Treatment as usual Behavioral: ENVIE psychoeducational program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.|
|Actual Study Start Date :||December 2, 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2022|
Treatment as usual
Other: Treatment as usual
Treatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants.
Experimental: Interventional group
ENVIE psychoeducational program
Behavioral: ENVIE psychoeducational program
The intervention will consist of 9 weekly, 90 min sessions led by two animators. The program ENVIE will provide:1.Presentation of the program 2.Education on depressive symptoms. 3.Information about the causes leading to depression. 4.The depression's consequences. 5.Teaching about the last neurobiological and neuroanatomical knowledges about depression, through didactic presentations. 6.How to recognize his own mood state, the prodromal symptoms of relapse. 7.Didactic explanation of the neurobiological action of antidepressant, and other evidence-based medical treatments. 8 and 9. Recommendations about lifestyle and skills of behavioral activation.To enhance the active role of the patient, each session will be accompanied with homework for the patient.
- Rate of remission of index episode at 15-months without relapse during follow-up [ Time Frame: 15 months after enrollment ]The primary endpoint will be the remission rate of the index episode at 15 months post-inclusion, defined by a Montgomery and Asberg Depression Rating Scale (MADRS) score ≤ 12 over an 8-week period, and without relapse during follow-up.
- Variation of depressive intensity using Medication Adherence Rating Scale (MADRS) [ Time Frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment ]
- Evolution of MADRS and BDI scores during follow-up; [ Time Frame: At the enrollment, then at 3, 6, 9 and 15 months ]
- Rate of response (decrease of MADRS score by 50%) [ Time Frame: At 15 months after enrollment ]
- Rate of relapse (MADRS > 12 after remission of index episode) [ Time Frame: At 15 months after enrollment ]
- Rate of hospitalisation during follow-up period [ Time Frame: At the enrollment, then at 3, 6, 9 and 15 months ]
- Variation of global functioning using the Functioning Assessment Short Test [ Time Frame: Between enrollment, and 9 and 15 months after enrollment ]
- Variation of quality of life using World Health Organization Quality Of Life measure-26 [ Time Frame: Between enrollment, and 9 and 15 months after enrollment ]
- Variation of treatment adherence using MADRS [ Time Frame: Between enrollment and 15 months after enrollment ]
- Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol) [ Time Frame: Between enrollment and 15 months after enrollment ]
- Discontinuation rate of the antidepressant treatment . [ Time Frame: At 15 months after enrollment ]
- Variation of depressive intensity using Beck Depression Inventory (BDI) scores [ Time Frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501226
|Contact: Emilie OLIE, MD, PhD||00 33 4 67 33 82 firstname.lastname@example.org|
|Contact: Déborah DUCASS, MD||00 33 4 67 33 82 email@example.com|
|University Hospital of Montpellier||Recruiting|
|Montpellier, France, 34295|
|Contact: Emilie OLIE|
|Principal Investigator:||Emilie OLIE, MD, PhD||University Hospital, Montpellier|