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Effectiveness of the First French Psychoeducational Program on Unipolar Depression (PURE)

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ClinicalTrials.gov Identifier: NCT02501226
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Groupe Hospitalier de la Rochelle Ré Aunis
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Béziers
University Hospital, Clermont-Ferrand
Centre Hospitalier Universitaire de Nice
Centre Hospitalier de l'Agglomération de Nevers
Centre Psychothérapique de Nancy
Hôpitaux à Bron
Assistance Publique - Hôpitaux de Paris
Centre Hospitalier Esquirol
Information provided by (Responsible Party):
University Hospital, Montpellier

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. Inded 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.


Condition or disease Intervention/treatment Phase
Unipolar Depressed Outpatients Mild Severity Without Psychotic Features Other: Treatment as usual Behavioral: ENVIE psychoeducational program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
Actual Study Start Date : December 2, 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control group
Treatment as usual
Other: Treatment as usual
Treatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants.

Experimental: Interventional group
ENVIE psychoeducational program
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.




Primary Outcome Measures :
  1. Rate of remission of index episode at 15-months without relapse during follow-up [ Time Frame: 15 months after enrollment ]
    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.


Secondary Outcome Measures :
  1. Variation of depressive intensity using Medication Adherence Rating Scale (MADRS) [ Time Frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment ]
  2. Evolution of MADRS and BDI scores during follow-up; [ Time Frame: At the enrollment, then at 3, 6, 9 and 15 months ]
  3. Rate of response (decrease of MADRS score by 50%) [ Time Frame: At 15 months after enrollment ]
  4. Rate of relapse (MADRS > 12 after remission of index episode) [ Time Frame: At 15 months after enrollment ]
  5. Rate of hospitalisation during follow-up period [ Time Frame: At the enrollment, then at 3, 6, 9 and 15 months ]
  6. Variation of global functioning using the Functioning Assessment Short Test [ Time Frame: Between enrollment, and 9 and 15 months after enrollment ]
  7. Variation of quality of life using World Health Organization Quality Of Life measure-26 [ Time Frame: Between enrollment, and 9 and 15 months after enrollment ]
  8. Variation of treatment adherence using MADRS [ Time Frame: Between enrollment and 15 months after enrollment ]
  9. Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol) [ Time Frame: Between enrollment and 15 months after enrollment ]
  10. Discontinuation rate of the antidepressant treatment . [ Time Frame: At 15 months after enrollment ]
  11. Variation of depressive intensity using Beck Depression Inventory (BDI) scores [ Time Frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • with a current diagnosis of substance abuse or dependence in the 6 months prior to inclusion, excluding tobacco
  • 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
  • hospitalized full-time at the time of inclusion
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501226


Contacts
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Contact: Emilie OLIE, MD, PhD 00 33 4 67 33 82 89 e-olie@chu-montpellier.fr
Contact: Déborah DUCASS, MD 00 33 4 67 33 82 89 d-ducasse@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Emilie OLIE         
Sponsors and Collaborators
University Hospital, Montpellier
Groupe Hospitalier de la Rochelle Ré Aunis
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Béziers
University Hospital, Clermont-Ferrand
Centre Hospitalier Universitaire de Nice
Centre Hospitalier de l'Agglomération de Nevers
Centre Psychothérapique de Nancy
Hôpitaux à Bron
Assistance Publique - Hôpitaux de Paris
Centre Hospitalier Esquirol
Investigators
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Principal Investigator: Emilie OLIE, MD, PhD University Hospital, Montpellier
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02501226    
Other Study ID Numbers: 9532
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Keywords provided by University Hospital, Montpellier:
Psychiatry
Depression
Psychoeducation
Randomized controlled trial
Treatment adherence
Remission
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders