NCT05824234

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2023May 2027

First Submitted

Initial submission to the registry

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Expected
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

March 28, 2023

Last Update Submit

March 4, 2025

Conditions

Mental Disorders

Outcome Measures

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.

    Two years

Secondary Outcomes (4)

  • Recovery Self-Assessment (RSA) health professional version to assess the perception of having a recovery-oriented practice

    One year

  • Self-stigma scale (Internalized Stigma of Mental Illness)

    One year

  • Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being

    One year

  • Qualitative component

    Two years

Study Arms (2)

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

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

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

Interventions

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

Arm number one (2023)
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

Arm number two (2024)

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41088104DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Julien DUBREUCQ, PH

    CHU ST ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine SIMON

CONTACT

0033661521509antoine.simon@ch-le-vinatier.fr

Julien DUBREUCQ, PhD

CONTACT

0033477127746julien.dubreucq@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial, with cluster randomization with sequential permutation or stepped wedge
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 21, 2023

Study Start

June 19, 2023

Primary Completion

May 15, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)