Unipolar Depressed OutpatientsPURENCT02501226
Effectiveness of the First French Psychoeducational Program on Unipolar Depression
A study testing Treatment as usual and ENVIE psychoeducational program in people with Unipolar Depressed Outpatients and Mild Severity, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unipolar Depressed Outpatients, Mild Severity, Without Psychotic Features
- What is being tested?
- Treatment as usual and ENVIE psychoeducational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2015to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Emilie OLIE
About this study
Official title: Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
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.
Read the 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.
- Being tested
- Treatment as usual, ENVIE psychoeducational program
- Keywords
- Psychiatry, Depression, Psychoeducation, Randomized controlled trial, Treatment adherence, Remission
- Medical subject headings
- Depression, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualOther
Treatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants.
ENVIE psychoeducational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Treatment as usual Receives: Other: Treatment as usual |
| Interventional group | Experimental | ENVIE psychoeducational program Receives: Behavioral: ENVIE psychoeducational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months after enrollment
Secondary outcomes (11)
Variation of depressive intensity using Medication Adherence Rating Scale (MADRS)
Measured: Between enrollment, and 3, 6, 9 and 15 months after enrollment
Evolution of MADRS and BDI scores during follow-up;
Measured: At the enrollment, then at 3, 6, 9 and 15 months
Rate of response (decrease of MADRS score by 50%)
Measured: At 15 months after enrollment
Rate of relapse (MADRS > 12 after remission of index episode)
Measured: At 15 months after enrollment
Rate of hospitalisation during follow-up period
Measured: At the enrollment, then at 3, 6, 9 and 15 months
Variation of global functioning using the Functioning Assessment Short Test
Measured: Between enrollment, and 9 and 15 months after enrollment
Variation of quality of life using World Health Organization Quality Of Life measure-26
Measured: Between enrollment, and 9 and 15 months after enrollment
Variation of treatment adherence using MADRS
Measured: Between enrollment and 15 months after enrollment
Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol)
Measured: Between enrollment and 15 months after enrollment
Discontinuation rate of the antidepressant treatment .
Measured: At 15 months after enrollment
Variation of depressive intensity using Beck Depression Inventory (BDI) scores
Measured: Between enrollment, and 3, 6, 9 and 15 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start2 Dec 2015
- Primary completionJun 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unipolar Depressed OutpatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Général de 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, Centre Hospitalier Sainte-Marie, Nice, Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Emilie OLIE, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501226
- Sponsor's protocol ID
- 9532
- Acronym
- PURE
- Status last verified
- Dec 2021
- First submitted
- 10 Jul 2015
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26578205
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the First French Psychoeducational Program on Unipolar Depression: Study Protocol for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02501226
- Acronym / sponsor ID
- PURE / 9532
- Keywords
- Psychiatry, Depression, Psychoeducation, Randomized controlled trial, Treatment adherence, Remission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Général de 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, Centre Hospitalier Sainte-Marie, Nice, Centre Hospitalier Universitaire de Nīmes
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Treatment as usualTreatment as usual |
| Interventional group | Experimental | Behavioral: ENVIE psychoeducational programENVIE psychoeducational program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualTreatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants. | Other | Control group |
| ENVIE psychoeducational programThe 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. | Behavioural | Interventional group |
Primary outcome
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.
11 secondary outcomes
Variation of depressive intensity using Medication Adherence Rating Scale (MADRS)
Time frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment
Evolution of MADRS and BDI scores during follow-up;
Time frame: At the enrollment, then at 3, 6, 9 and 15 months
Rate of response (decrease of MADRS score by 50%)
Time frame: At 15 months after enrollment
Rate of relapse (MADRS > 12 after remission of index episode)
Time frame: At 15 months after enrollment
Rate of hospitalisation during follow-up period
Time frame: At the enrollment, then at 3, 6, 9 and 15 months
Variation of global functioning using the Functioning Assessment Short Test
Time frame: Between enrollment, and 9 and 15 months after enrollment
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
Variation of treatment adherence using MADRS
Time frame: Between enrollment and 15 months after enrollment
Variation of benzodiazepines doses (data collection, no modification treatment according to the protocol)
Time frame: Between enrollment and 15 months after enrollment
Discontinuation rate of the antidepressant treatment .
Time frame: At 15 months after enrollment
Variation of depressive intensity using Beck Depression Inventory (BDI) scores
Time frame: Between enrollment, and 3, 6, 9 and 15 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Derived from this study: PubMed 26578205Ducasse 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.
Related trials for Unipolar Depressed Outpatients
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Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Depressive Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie OLIE, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual and ENVIE psychoeducational program in people with Unipolar Depressed Outpatients and Mild Severity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie OLIE, MD, PhD (00 33 4 67 33 82 89, e-olie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of remission of index episode at 15-months without relapse during follow-up (time frame: 15 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.