ClinicalTrials.gg
RecruitingNCT05824234RETAFORMUpdated Jun 12, 2026

Implementation of REFOCUS Training Program in Mental Health Services

An interventional study of 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 Mental Disorders, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
760
Allocation
Randomized
Ages
15 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mental Disorders

Browse trials for

03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 760 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( 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

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 ).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
760 participants (estimated)

Study arms

  • 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

    Other: Implementation of a training centered around the notions of recovery with mental health services first year

  • 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

    Other: Implementation of a training centered around the notions of recovery with mental health services second year

Interventions

  • OtherImplementation of a training centered around the notions of recovery with mental health services first year

    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

  • OtherImplementation of a training centered around the notions of recovery with mental health services second year

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two years

Secondary outcomes

  1. 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.

    Time frame: One year

  2. Self-stigma scale (Internalized Stigma of Mental Illness)

    Intra- and inter-group comparison of scores on the following scale

    Time frame: One year

  3. 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.

    Time frame: One year

  4. 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

    Time frame: Two years

07

Study locations

1 of 1 sites recruiting
  • centre de réhabilitation - Hôpital le Vinatier
    Lyon, Rhône 69006, France
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Dec 2026, 42 months after the start.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 42 months is above that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
Apr 21, 2023
StartActual
Jun 19, 2023
Primary completionEst.
Dec 19, 2026
CompletionEst.
Jun 30, 2027
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05824234
Responsible party
Sponsor
First posted
Apr 21, 2023
Start date
Jun 19, 2023
Primary completion
Dec 19, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Antoine SIMON
Contact
antoine.simon@ch-le-vinatier.fr
0033661521509
Julien DUBREUCQ, PhD
Contact
julien.dubreucq@chu-st-etienne.fr
0033477127746
Julien DUBREUCQ, PH
principal investigator · CHU ST ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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