Effectiveness of the First French Psychoeducational Program on Unipolar Depression

NCT02501226 | Unknown

• 1 other identifier: 9532
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Unipolar Depressed Outpatients; Mild Severity; Without Psychotic Features

Keywords

Psychiatry; Depression; Psychoeducation; Randomized controlled trial; Treatment adherence; Remission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Variation of depressive intensity using Medication Adherence Rating Scale (MADRS)

  Between enrollment, and 3, 6, 9 and 15 months after enrollment

• Evolution of MADRS and BDI scores during follow-up;

  At the enrollment, then at 3, 6, 9 and 15 months

• Rate of response (decrease of MADRS score by 50%)

  At 15 months after enrollment

• Rate of relapse (MADRS > 12 after remission of index episode)

  At 15 months after enrollment

• Rate of hospitalisation during follow-up period

  At the enrollment, then at 3, 6, 9 and 15 months

Study Arms (2)

Control group

OTHER

Treatment as usual

Other: Treatment as usual

Interventional group

EXPERIMENTAL

ENVIE psychoeducational program

Behavioral: ENVIE psychoeducational program

Interventions

Treatment as usual OTHER

Treatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants.

Control group

ENVIE psychoeducational program BEHAVIORAL

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. The sessions may be carried out remotely, by videoconference.

Interventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Groupe Hospitalier de la Rochelle Ré Aunis: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Centre Hospitalier Général de Béziers: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Centre Hospitalier de l'Agglomération de Nevers: collaborator
• Centre Psychothérapique de Nancy: collaborator
• Hôpitaux à Bron: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• Centre Hospitalier Esquirol: collaborator
• Centre Hospitalier Sainte-Marie, Nice: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• Ducasse D, Courtet P, Seneque M, Genty C, Picot MC, Schwan R, Olie E. Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Nov 17;15:294. doi: 10.1186/s12888-015-0667-7.

  PMID: 26578205 DERIVED

MeSH Terms

Conditions

Depression; Treatment Adherence and Compliance

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Health Behavior

Study Officials

• Emilie OLIE, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie OLIE, MD, PhD

CONTACT

00 33 4 67 33 82 89; e-olie@chu-montpellier.fr

Déborah DUCASS, MD

CONTACT

00 33 4 67 33 82 89; d-ducasse@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 17, 2015
• Study Start: December 2, 2015
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

FR (1)