Mild Severity Clinical Trial
— PUREOfficial title:
Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
| NCT number | NCT02501226 |
| Other study ID # | 9532 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2, 2015 |
| Est. completion date | June 2023 |
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. Indeed 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.
| Status | Recruiting |
| Enrollment | 332 |
| Est. completion date | June 2023 |
| Est. primary completion date | June 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - aged 18-65 years - with a main diagnosis of non-psychotic non-chronic (<2 years) major depressive episode (DSM-IV criteria) of moderate to severe intensity (Montgomery Asberg Depression Scale score > 24) - taking at least one antidepressant - able to speak, read and understand French - and able to give written informed consent Exclusion Criteria: - current psychotic features - duration of current depressive episode >2 years - current organic mental disorder or mental retardation, or severe comorbid medical condition - lifetime history of schizophrenia, or schizoaffective or bipolar disorder, manic, hypomanic, or mixed episodes according to DSM-IV criteria - sensory or cognitive disabilities - having a relationship or being employed by the sponsor or investigator. - We will also exclude patients who are planning a long stay outside the region preventing compliance with the scheduled visits, and subjects participating in another trial. |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Assistance Publique - Hôpitaux de Paris, Centre Hospitalier de l'Agglomération de Nevers, Centre Hospitalier Esquirol, Centre Hospitalier Général de Béziers, Centre Hospitalier Sainte-Marie, Nice, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire de Nimes, Centre Psychothérapique de Nancy, Groupe Hospitalier de la Rochelle Ré Aunis, Hôpitaux à Bron, University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of remission of index episode at 15-months without relapse during follow-up | 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. | 15 months after enrollment | |
| Secondary | Variation of depressive intensity using Medication Adherence Rating Scale (MADRS) | Between enrollment, and 3, 6, 9 and 15 months after enrollment | ||
| Secondary | Evolution of MADRS and BDI scores during follow-up; | At the enrollment, then at 3, 6, 9 and 15 months | ||
| Secondary | Rate of response (decrease of MADRS score by 50%) | At 15 months after enrollment | ||
| Secondary | Rate of relapse (MADRS > 12 after remission of index episode) | At 15 months after enrollment | ||
| Secondary | Rate of hospitalisation during follow-up period | At the enrollment, then at 3, 6, 9 and 15 months | ||
| Secondary | Variation of global functioning using the Functioning Assessment Short Test | Between enrollment, and 9 and 15 months after enrollment | ||
| Secondary | Variation of quality of life using World Health Organization Quality Of Life measure-26 | Between enrollment, and 9 and 15 months after enrollment | ||
| Secondary | Variation of treatment adherence using MADRS | Between enrollment and 15 months after enrollment | ||
| Secondary | Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol) | Between enrollment and 15 months after enrollment | ||
| Secondary | Discontinuation rate of the antidepressant treatment . | At 15 months after enrollment | ||
| Secondary | Variation of depressive intensity using Beck Depression Inventory (BDI) scores | Between enrollment, and 3, 6, 9 and 15 months after enrollment |