Mental DisordersRETAFORMNCT05824234
Implementation of REFOCUS Training Program in Mental Health Services
A study testing Implementation of a training centered around the notions of recovery with mental health services first year and Implementation of a training centered around the notions of recovery with mental health services second year in people with Mental Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Implementation of a training centered around the notions of recovery with mental health services first year and Implementation of a training centered around the notions of recovery with mental health services second year
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
centre de réhabilitation - Hôpital le Vinatier
Lyon, Rhône, 69006
Franck Nicolas, PUPH, +33 (0)4 26 23 76 11, nicolas.franck@ch-le-vinatier.fr
Gaudelus Baptiste, +33 (0)4 26 23 76 11, baptiste.gaudelus@ch-le-vinatier.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Implementation of a training centered around the notions of recovery with mental health services first year, Implementation of a training centered around the notions of recovery with mental health services second year
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a training centered around the notions of recovery with mental health services first yearOther
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
Implementation of a training centered around the notions of recovery with mental health services second yearOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm number one (2023) | Other | 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 Receives: Other: Implementation of a training centered around the notions of recovery with mental health services first year |
| Arm number two (2024) | Other | 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 Receives: Other: Implementation of a training centered around the notions of recovery with mental health services second year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire about the Process of Recovery QPR Intra- and inter-group comparison in users with severe psychiatric disorders
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.
Measured: Two years
Secondary outcomes (4)
Recovery Self-Assessment (RSA) health professional version to assess the perception of having a recovery-oriented practice
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.
Measured: One year
Self-stigma scale (Internalized Stigma of Mental Illness)
Intra- and inter-group comparison of scores on the following scale
Measured: One year
Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being
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.
Measured: One year
Qualitative component
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start19 Jun 2023
- Primary completion19 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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 Mental DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial, with cluster randomization with sequential permutation or stepped wedge
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien DUBREUCQ, PH, Principal investigator, CHU ST ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824234
- Sponsor's protocol ID
- 2021-A03025-36
- Acronym
- RETAFORM
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dubreucq J, Franck N, Plasse J, Muller AE, Bralet MC, Bera-Potelle C, Berna F, Blachere C, Carpentier A, Chereau I, Chillet P, Dubreucq M, Durand-Zaleski I, Chirio-Espitalier M, Espi P, Fourneret P, Gabriel-Segard T, Guioux A, Grange AL, Green A, Green E, Guillard-Bouhet N, Gerardin P, Harscoet YA, Khazaal Y, Lassere E, Le Bras A, Leamy M, Legrand G, Legros-Lafarge E, Llorca PM, Jaafari N, Mabille L, Masson D, Massoubre C, Moisset A, Nahabedian N, Quiles C, Reydellet D, Simon A, Sibert A, Tresse R, Tinland A, Meadows G, Slade M; RETAFORM study group. Evaluation of a pro-recovery training intervention (REFOCUS-RETAFORM) in specialist mental health services across France: stepped-wedge cluster randomised controlled trial protocol. BMC Psychiatry. 2025 Oct 14;25(1):982. doi: 10.1186/s12888-025-07253-w.
PubMed 41088104
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services
- ClinicalTrials.gov ID
- NCT05824234
- Acronym / sponsor ID
- RETAFORM / 2021-A03025-36
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with cluster randomization with sequential permutation or stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Arm number one (2023) | Other | Other: Implementation of a training centered around the notions of recovery with mental health services first yearArm 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 |
| Arm number two (2024) | Other | Other: Implementation of a training centered around the notions of recovery with mental health services second yearArm 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 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Implementation of a training centered around the notions of recovery with mental health services first yearStepped 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 one (2023) |
| Implementation of a training centered around the notions of recovery with mental health services second yearStepped 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) |
Primary outcome
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.
4 secondary outcomes
Recovery Self-Assessment (RSA) health professional version to assess the perception of having a recovery-oriented practice
Time frame: One year
Self-stigma scale (Internalized Stigma of Mental Illness)
Time frame: One year
Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being
Time frame: One year
Qualitative component
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 41088104Dubreucq J, Franck N, Plasse J, Muller AE, Bralet MC, Bera-Potelle C, Berna F, Blachere C, Carpentier A, Chereau I, Chillet P, Dubreucq M, Durand-Zaleski I, Chirio-Espitalier M, Espi P, Fourneret P, Gabriel-Segard T, Guioux A, Grange AL, Green A, Green E, Guillard-Bouhet N, Gerardin P, Harscoet YA, Khazaal Y, Lassere E, Le Bras A, Leamy M, Legrand G, Legros-Lafarge E, Llorca PM, Jaafari N, Mabille L, Masson D, Massoubre C, Moisset A, Nahabedian N, Quiles C, Reydellet D, Simon A, Sibert A, Tresse R, Tinland A, Meadows G, Slade M; RETAFORM study group. Evaluation of a pro-recovery training intervention (REFOCUS-RETAFORM) in specialist mental health services across France: stepped-wedge cluster randomised controlled trial protocol. BMC Psychiatry. 2025 Oct 14;25(1):982. doi: 10.1186/s12888-025-07253-w.
- Individual participant dataSharing planned: No
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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.
Julien DUBREUCQ, PH principal investigator
CHU ST ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a training centered around the notions of recovery with mental health services first year and Implementation of a training centered around the notions of recovery with mental health services second year in people with Mental Disorders, run by Hôpital le Vinatier 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine SIMON (0033661521509, antoine.simon@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire about the Process of Recovery QPR Intra- and inter-group comparison in users with severe psychiatric disorders (time frame: Two years). 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 NCT05824234, 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 12 Jun 2026.