Implementation of REFOCUS Training Program in Mental Health Services

Mental Disorders Clinical Trial

— RETAFORM  

Official title:

Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824234
• Other study ID #: 2021-A03025-36
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: May 30, 2027

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: Antoine SIMON
• Phone: 0033661521509
• Email: antoine.simon[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: May 30, 2027
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mental Disorders

Intervention

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
• 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

Locations

Country	Name	City	State
France	centre de réhabilitation - Hôpital le Vinatier	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	One year
Secondary	Self-stigma scale (Internalized Stigma of Mental Illness)	Intra- and inter-group comparison of scores on the following scale	One year
Secondary	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.	One year
Secondary	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	Two years