Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02501226
Status:
UNKNOWN
Last Update Posted:
2022-01-03
First Post:
2015-07-10
Brief Title:
Effectiveness of the First French Psychoeducational Program on Unipolar Depression
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Effectiveness of the First French Psychoeducational Program on Unipolar Depression Study Protocol for a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURE
Brief Summary:
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
MethodsDesign 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 N166 or to a waiting list N166 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
MethodsDesign 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 N166 or to a waiting list N166 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
Detailed Description:
The investigators propose to study the rate of remission at 15-month follow-up and time to achieve remission of index episode in a multicentric randomized controlled trial using ENVIE program and treatment as usual versus treatment as usual only The investigators will include depressed subjects suffering from non a first depressive episode as well as recurrent episodeThe eligible patients will be randomized into two groups computer-generated randomisation in a 1 1 ratio blocked in groups of 4 stratified on the number of episodes 1 2 3 and more Only outpatients consulting in the investigation centres will be recruited Sociodemographic data psychiatric diagnoses using Mini-International Neuropsychiatric Interview MINI and Screening Interview for Axis II Disorder SCID-II for borderline personality disorder pharmacological treatment will be also recorded Patients will be assessed by clinicians blind to treatment allocation at inclusion before intervention and at 3 months end of the intervention 6 9 and 15 months after the inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None