Clinical trial NCT02501226: Effectiveness of the First French Psychoeducational Program on Unipolar Depression
Official title: Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unipolar Depressed Outpatients
Mild Severity
Without Psychotic Features
Keywords: Psychiatry
Depression
Psychoeducation
Randomized controlled trial
Treatment adherence
Remission
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier de la Rochelle Ré Aunis
name: Centre Hospitalier Universitaire de Besancon
name: Centre Hospitalier Général de Béziers
name: University Hospital, Clermont-Ferrand
name: Centre Hospitalier Universitaire de Nice
name: Centre Hospitalier de l'Agglomération de Nevers
name: Centre Psychothérapique de Nancy
name: Hôpitaux à Bron
name: Assistance Publique - Hôpitaux de Paris
name: Centre Hospitalier Esquirol
name: Centre Hospitalier Sainte-Marie, Nice
name: Centre Hospitalier Universitaire de Nīmes
First posted: 2015-07-17
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 episode.The 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 (M.I.N.I.) 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of remission of index episode at 15-months without relapse during follow-up
timeFrame: 15 months after enrollment
Secondary outcomes:
measure: Variation of depressive intensity using Medication Adherence Rating Scale (MADRS)
timeFrame: Between enrollment, and 3, 6, 9 and 15 months after enrollment
measure: Evolution of MADRS and BDI scores during follow-up;
timeFrame: At the enrollment, then at 3, 6, 9 and 15 months
measure: Rate of response (decrease of MADRS score by 50%)
timeFrame: At 15 months after enrollment
measure: Rate of relapse (MADRS > 12 after remission of index episode)
timeFrame: At 15 months after enrollment
measure: Rate of hospitalisation during follow-up period
timeFrame: At the enrollment, then at 3, 6, 9 and 15 months
measure: Variation of global functioning using the Functioning Assessment Short Test
timeFrame: Between enrollment, and 9 and 15 months after enrollment
measure: Variation of quality of life using World Health Organization Quality Of Life measure-26
timeFrame: Between enrollment, and 9 and 15 months after enrollment
measure: Variation of treatment adherence using MADRS
timeFrame: Between enrollment and 15 months after enrollment
measure: Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol)
timeFrame: Between enrollment and 15 months after enrollment
measure: Discontinuation rate of the antidepressant treatment .
timeFrame: At 15 months after enrollment
measure: Variation of depressive intensity using Beck Depression Inventory (BDI) scores
timeFrame: Between enrollment, and 3, 6, 9 and 15 months after enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Emilie OLIE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.