RETAFORM: Implementation of REFOCUS Training Program in Mental Health Services

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05824234
Collaborator
(none)
760
2
48.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Implementation of a training centered around the notions of recovery with mental health services first year
  • Other: Implementation of a training centered around the notions of recovery with mental health services second year
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
760 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized controlled trial, with cluster randomization with sequential permutation or stepped wedgeRandomized controlled trial, with cluster randomization with sequential permutation or stepped wedge
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
May 15, 2026
Anticipated Study Completion Date :
May 30, 2027

Arms and Interventions

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

Other: Implementation 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

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
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

Outcome Measures

Primary Outcome Measures

  1. Questionnaire about the Process of Recovery QPR Intra- and inter-group comparison in users with severe psychiatric disorders [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.

Secondary Outcome Measures

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

  2. Self-stigma scale (Internalized Stigma of Mental Illness) [One year]

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

  3. Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being [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.

  4. Qualitative component [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

  • Principal Investigator: Julien DUBREUCQ, PH, CHU ST ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT05824234
Other Study ID Numbers:
  • 2021-A03025-36
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023