Effectiveness of the First French Psychoeducational Program on Unipolar Depression

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

Interventions

OTHER

Treatment as usual

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

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

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Centre Hospitalier Général de Béziers

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Centre Hospitalier de l'Agglomération de Nevers

  collaborator OTHER

• Centre Psychothérapique de Nancy

  collaborator OTHER

• Hôpitaux à Bron

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Centre Hospitalier Esquirol

  collaborator OTHER

• Centre Hospitalier Sainte-Marie, Nice

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Emilie OLIE, MD, PhD · University Hospital, Montpellier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-02

Primary Completion

2022-06-30

Completion

2023-06-30

Countries

• France

Study Locations