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Implementation of REFOCUS Training Program in Mental Health Services (RETAFORM)

Primary Purpose

Mental Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation of a training centered around the notions of recovery with mental health services first year
Implementation of a training centered around the notions of recovery with mental health services second year
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Disorders

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Arm number one (2023)

    Arm number two (2024)

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Self-stigma scale (Internalized Stigma of Mental Illness)
    Intra- and inter-group comparison of scores on the following scale
    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.
    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

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    April 19, 2023
    Sponsor
    Hôpital le Vinatier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05824234
    Brief Title
    Implementation of REFOCUS Training Program in Mental Health Services
    Acronym
    RETAFORM
    Official Title
    Multicenter Study on the Implementation of a Training Program in the Orientation of Care Towards Recovery (REFOCUS) in Mental Health Services
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2026 (Anticipated)
    Study Completion Date
    May 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hôpital le Vinatier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorders

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized controlled trial, with cluster randomization with sequential permutation or stepped wedge
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    760 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm number one (2023)
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    Arm number two (2024)
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Implementation of a training centered around the notions of recovery with mental health services first year
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Implementation of a training centered around the notions of recovery with mental health services second year
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Questionnaire about the Process of Recovery QPR Intra- and inter-group comparison in users with severe psychiatric disorders
    Description
    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 Outcome Measure Information:
    Title
    Recovery Self-Assessment (RSA) health professional version to assess the perception of having a recovery-oriented practice
    Description
    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
    Title
    Self-stigma scale (Internalized Stigma of Mental Illness)
    Description
    Intra- and inter-group comparison of scores on the following scale
    Time Frame
    One year
    Title
    Warwick-Edinburgh Mental Well Being Scale (WEMWBS) for mental well-being
    Description
    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
    Title
    Qualitative component
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antoine SIMON
    Phone
    0033661521509
    Email
    antoine.simon@ch-le-vinatier.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julien DUBREUCQ, PhD
    Phone
    0033477127746
    Email
    julien.dubreucq@chu-st-etienne.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julien DUBREUCQ, PH
    Organizational Affiliation
    CHU ST ETIENNE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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