- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05824234
Implementation of REFOCUS Training Program in Mental Health Services (RETAFORM)
June 10, 2026 updated by: Hôpital le Vinatier
Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services
Training of mental health service teams in the orientation of care towards recovery through a 3-day training course: REFOCUS.
This training aims to orient care towards recovery.
Following this training, evaluation of the effectiveness of the implementation of REFOCUS training in mental health services.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The primary hypothesis is that the implementation of REFOCUS will facilitate the 1-year recovery of patients managed by trained professionals.
The secondary hypotheses are that the implementation of REFOCUS will facilitate improved orientation of practices towards recovery; reduced costs associated with the use of mental health services; improved perceived stigma, self-stigma, stigma-related stress, well-being, perceived coercion, and general functioning among those involved.
Study Type
Interventional
Enrollment (Estimated)
760
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antoine SIMON
- Phone Number: 0033661521509
- Email: antoine.simon@ch-le-vinatier.fr
Study Contact Backup
- Name: Julien DUBREUCQ, PhD
- Phone Number: 0033477127746
- Email: julien.dubreucq@chu-st-etienne.fr
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69006
- Recruiting
- centre de réhabilitation - Hôpital le Vinatier
-
Contact:
- Franck Nicolas, PUPH
- Phone Number: +33 (0)4 26 23 76 11
- Email: nicolas.franck@ch-le-vinatier.fr
-
Contact:
- Gaudelus Baptiste
- Phone Number: +33 (0)4 26 23 76 11
- Email: baptiste.gaudelus@ch-le-vinatier.fr
-
Principal Investigator:
- Franck Nicolas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age from 15 to 65 years old.
- Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder and schizophreniform disorder or bipolar disorder, borderline personality disorder, disabling anxiety or depressive disorder (DSM-V criteria; APA, 2013).
- Patients cared for by the team or unit benefiting from REFOCUS training
- French mother tongue.
- Patient affiliated or entitled to a social security scheme
- Patient having received information about the study and having confirmed their participation in the study by signing the consent form
- For minors (< 18 years), information given to holders of parental authority and signature of consent.
- For patients under curatorship, form signed by the patient and information given to the curator
Exclusion Criteria:
- Age less than 15 years old
- Patients under guardianship
- Presence of an associated intellectual disability
- Neurological disorders of vascular, infectious or neurodegenerative origin.
- Taking somatic drugs with a cerebral or psychic impact (eg corticosteroids).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm number one (2023)
Arm number one: services formed the first year with the REFOCUS formation Arm number two: services formed the second year with the REFOCUS formation Stepped wedge methodology
|
Stepped wedge design so same procedure for both arms Stepped-wedge design with randomization stratified by cluster (training over the 1st or 2nd year) according to professional practice (intra-hospital, CMP / CATTP, day hospital, Psychosocial Rehabilitation Center, mobile team, medical sector) social) of the teams formed by the 18 centers participating in the study
|
|
Other: Arm number two (2024)
Arm number one: services formed the first year with the REFOCUS formation Arm number two: services formed the second year with the REFOCUS formation Stepped wedge methodology
|
Stepped wedge design so same procedure for both arms Stepped-wedge design with randomization stratified by cluster (training over the 1st or 2nd year) according to professional practice (intra-hospital, CMP / CATTP, day hospital, Psychosocial Rehabilitation Center, mobile team, medical sector) social) of the teams formed by the 18 centers participating in the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire about the Process of Recovery QPR Intra- and inter-group comparison in users with severe psychiatric disorders
Time Frame: Two years
|
Intra- and inter-group comparison of the score on the self-assessment scale of the stage of recovery (Questionnaire about the Process of Recovery; QPR) in users with severe psychiatric disorders The QPR has 15 items each scored on a 4-point scale (0= disagree strongly, 1=disagree, 2=neither agree nor disagree, 3=agree, 4=agree strongly).
Higher scores are indicative of recovery.
However, those involved in developing this measure suggest that scores should not only be added to give total scores, but the QPR should be used as described above e.g. as a tool for considering personal goals for recovery, health and wellbeing.
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery Self-Assessment (RSA) health professional version to assess the perception of having a recovery-oriented practice
Time Frame: One year
|
Intra- and inter-group comparison of scores on the following scales: The Recovery Self-Assessment (RSA) is a 36-item measure designed to gauge the degree to which programs implement recovery-oriented practices. It is a self-reflective tool designed to identify strengths and target areas of improvement as agencies and systems strive to offer recovery-oriented care. |
One year
|
|
Self-stigma scale (Internalized Stigma of Mental Illness)
Time Frame: One year
|
Intra- and inter-group comparison of scores on the following scale
|
One year
|
|
Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being
Time Frame: One year
|
Intra- and inter-group comparison of scores on the following scale Scoring.
The 14-item scale WEMWBS is very simple to score.
The total score is obtained by summing the score for each of the 14 items.
The scoring range for each item is from 1 - 5 and the total score is from 14-70.
|
One year
|
|
Qualitative component
Time Frame: Two years
|
A qualitative analysis will be conducted with trainers, trained mental health professionals and patients followed by trained professionals, using semi-structured individual interviews or focus groups.
For this study, participants will be asked about their experience following the implementation of REFOCUS training in recovery-oriented practices.
The focus groups will be facilitated by at least two members of the research team, recorded with the participants' consent and fully transcribed.
They will be conducted until data saturation is achieved.
The data will be analysed using the thematic content analysis method.
The COREQ grid will be used to write the protocol and analyse the results.
Multiple triangulation of the data will help to refine the understanding of the problem and limit the risk of interpretation bias
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julien DUBREUCQ, PH, CHU St Etienne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2023
Primary Completion (Estimated)
December 19, 2026
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
April 19, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A03025-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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