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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05824234
Other study ID # 2021-A03025-36
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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