title: Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial.
abstract: 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. Indded psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France.
  
  
  METHODS
  We propose to evaluate the first French psychoeducational program for depression "ENVIE" in a multicenter randomized controlled trial. The group intervention will include 9 weekly sessions. 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. 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. We will also assess the response rate and relapse at 15 months post-inclusion, hospitalization rate and adherence to treatment during the follow-up period, quality of life and global functioning upon inclusion and at 9 and 15 months post inclusion.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial is registered under number 2015-A00249-40 (PURE clinical trial: NCT02501226 ) (June 30th, 2015).
authors.affiliation: Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, Hôpital Lapeyronie, 371 Avenue Gaston Giraud, 34295, Montpellier, France. d-ducasse@chu-montpellier.fr.|Inserm, U1061 Montpellier, University of Montpellier, Montpellier, France. d-ducasse@chu-montpellier.fr.|FondaMental Foundation, ᅟ, France. d-ducasse@chu-montpellier.fr.
authors.forename: Déborah
authors.initials: D
authors.lastname: Ducasse
authors.affiliation: Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, Hôpital Lapeyronie, 371 Avenue Gaston Giraud, 34295, Montpellier, France. p-courtet@chu-montpellier.fr.|Inserm, U1061 Montpellier, University of Montpellier, Montpellier, France. p-courtet@chu-montpellier.fr.|FondaMental Foundation, ᅟ, France. p-courtet@chu-montpellier.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Courtet
authors.affiliation: Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, Hôpital Lapeyronie, 371 Avenue Gaston Giraud, 34295, Montpellier, France. maude.seneque@inserm.fr.|Inserm, U1061 Montpellier, University of Montpellier, Montpellier, France. maude.seneque@inserm.fr.|FondaMental Foundation, ᅟ, France. maude.seneque@inserm.fr.
authors.forename: Maude
authors.initials: M
authors.lastname: Sénèque
authors.affiliation: Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, Hôpital Lapeyronie, 371 Avenue Gaston Giraud, 34295, Montpellier, France. catherine.genty@inserm.fr.|Inserm, U1061 Montpellier, University of Montpellier, Montpellier, France. catherine.genty@inserm.fr.|FondaMental Foundation, ᅟ, France. catherine.genty@inserm.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Genty
authors.affiliation: Clinical & Epidemiological Reseach Unit, CHU, Montpellier, France. mc-picot@chu-montpellier.fr.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Picot
authors.affiliation: Psychotherapeutic center of Nancy, CHU, Nancy, France. raymund.schwan@univ-lorraine.fr.
authors.forename: Raymund
authors.initials: R
authors.lastname: Schwan
authors.affiliation: Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, Hôpital Lapeyronie, 371 Avenue Gaston Giraud, 34295, Montpellier, France. e-olie@chu-montpellier.fr.|Inserm, U1061 Montpellier, University of Montpellier, Montpellier, France. e-olie@chu-montpellier.fr.|FondaMental Foundation, ᅟ, France. e-olie@chu-montpellier.fr.
authors.forename: Emilie
authors.initials: E
authors.lastname: Olié
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003865:Major Depressive Disorder / Q000628:therapy*; D005260:Female; D005602:France; D017048:Health Care Costs; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010045:Outpatients; D010353:Patient Education as Topic / Q000379:methods*; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult; D000092864:Suicide Prevention