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Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area (PASSVERS-2)

Primary Purpose

Severe Mental Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient group/Passvers
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Mental Disorder focused on measuring Schizophrenia, Bipolar disorder, Autism

Eligibility Criteria

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

Inclusion Criteria:

  • Presence of a severe and persistent mental disorder among the following ICD10 compliant diagnostic categories:

    • Schizophrenia spectrum disorder (F2x)
    • Recurrent or persistent mood disorders (F30.x, F31.x, F33.x, F34.x, F38.x)
    • Psychological developmental disorders including autism spectrum disorders (F8x) and childhood and adolescent onset disorders (F9x)
  • Presence of an indication for inclusion in the rehabilitation project identified by the treating psychiatrist and endorsed in the inclusion session by the PASSVers staff.
  • Written consent from the patient or his/her legal representative to participate in the study.

Exclusion Criteria:

  • Presence of an not stabilized or progressive organic neurological pathology, neurodegenerative disease
  • Psychological or behavioral disorders mainly related to addictions with substances
  • Psychiatric disorders secondary to an organic pathology that is not stabilized or that is evolving

  • The following psychiatric situations are reasons for non-inclusion in the absence of an argued and collegial reassessment (the reason being that, although PASSVers2 must be considered as a first intention proposal in many situations meeting the inclusion criteria, it cannot intervene or be thought of as a "solution" to certain complex situations):

    • Psychiatric disorders caused by pregnancy or immediate postpartum
    • Severe borderline personality disorder
    • Current suicidal crisis
    • Extreme fragility of the patient with respect to changes that may be induced by the project, associated with a high risk of self or hetero-aggression.
    • Patient under justice constraint
  • Foreseeable departure from the geographic area, not allowing for certainty of further evaluation
  • Refusal of the patient to be followed by a social-health team (i.e. refusal of care or refusal of a dialogue on social aspects and projects).

Sites / Locations

  • Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
  • Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
  • Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
  • Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
  • Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient group (single group)

Arm Description

300 Patients involved in the recovery process.

Outcomes

Primary Outcome Measures

Patient self rating of recovery support by caregivers T0
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers T12
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers and structure T0
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient self rating of recovery support by caregivers and structure T12
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient functioning T0
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient functioning T12
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient functioning T24
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient self rating of quality of life T0
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Patient self rating of quality of life T12
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Patient self rating of quality of life T24
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Psychotic symptoms T0
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Psychotic symptoms T12
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Depression T0
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Depression T12
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Clinical outcome T0: Clinically significant events
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Clinical outcome T12: Clinically significant events
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Patient self rating of recovery T0
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient self rating of recovery T12
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient self rating of recovery T24
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery

Secondary Outcome Measures

Professional's Recovery knowledge on patients T0
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Professional's Recovery knowledge on patients T12
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Professional's Recovery opinions on patients T0
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Professional's Recovery opinions on patients T12
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Stigmatization T0
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Stigmatization T12
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Perceived needs T0
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Perceived needs T12
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Goal achievement T12
Goal achievement scale (GAS), range -2 to +2, higher values correspond to better achievement of one specific goal
Metacognitive strategies T0
Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies
Sleep T0
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Sleep T12
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Medication adherence T0
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Medication adherence T12
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Illness severity T0
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Illness severity T12
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Cognitive disability T0
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Cognitive disability T12
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Entourage assessment of structure recovery orientation T0
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation
Entourage assessment of structure recovery orientation T12
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation

Full Information

First Posted
February 15, 2022
Last Updated
March 24, 2022
Sponsor
Versailles Hospital
Collaborators
Agence régionale de santé Ile de France, UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
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1. Study Identification

Unique Protocol Identification Number
NCT05274126
Brief Title
Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area
Acronym
PASSVERS-2
Official Title
Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
Collaborators
Agence régionale de santé Ile de France, UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES

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
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.
Detailed Description
This is a hybrid efficacy-implementation Type I recovery based interventional study based on a multicenter follow-up of a cohort of 300 patients with severe and persistent mental disorders (60 patients per center). The evolution of concepts and means of evaluation now allow a precise description of the mechanisms of recovery in all the diversity of its expression among patients, their entourages and the psychiatric facilities. In the present study, the investigators aim to characterize simultaneously the patients' trajectories and the evolution of the care facilities and their professionals with respect to the principles of recovery. This double exploration should allow to build theoretical and practical references for the extension of this approach to other centers in France. The study considers a dual timeline for data collection: The timeline associated with patients defined by the inclusion of each patient and extending to 24 months after, punctuated by an assessment at 12 months; The timeline of the inclusion centers and professionals involved in the rehabilitation projects defined by the beginning of the study and extending beyond the end of inclusion of the last patient, punctuated by annual intermediate evaluations of the means allocated by the structure and the positioning of the personnel in terms of recovery. The intervention consists in a follow-up of the patients and their relatives by a psychiatric nurse and a social worker during 12 months. Both professionals, trained to rehabilitation and recovery principles, will focus on the patient's needs and goals in order to improve the outcome, quality-of-life and clinical status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Disorder
Keywords
Schizophrenia, Bipolar disorder, Autism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group (single group)
Arm Type
Experimental
Arm Description
300 Patients involved in the recovery process.
Intervention Type
Behavioral
Intervention Name(s)
Patient group/Passvers
Intervention Description
Passvers intervention aims at : helping patients followed in the centers, presenting a Severe and Persistent Mental Disorder (schizophrenia, mood disorder, autism spectrum disorder, etc.), at risk or in a situation of psychological disability, to enroll in a rehabilitation program towards recovery. supporting the emergence and construction of projects by the people themselves, and to accompany them to realize them. Encouraging the use of resources in their environment and common law mechanisms (city hall, department, associations, etc.) for better social integration. encouraging involvement in care understood as useful tools for the realization of the personal project. Passvers also aims at : promoting a change in professional practices within the team, in favor of recovery-oriented practices based on the concept of engagement or empowerment. allowing cooperation between health and social structures aiming at destigmatizing mental illness.
Primary Outcome Measure Information:
Title
Patient self rating of recovery support by caregivers T0
Description
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Time Frame
baseline
Title
Patient self rating of recovery support by caregivers T12
Description
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Time Frame
1 year
Title
Patient self rating of recovery support by caregivers and structure T0
Description
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Time Frame
baseline
Title
Patient self rating of recovery support by caregivers and structure T12
Description
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Time Frame
1 year
Title
Patient functioning T0
Description
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Time Frame
baseline
Title
Patient functioning T12
Description
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Time Frame
1 year
Title
Patient functioning T24
Description
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Time Frame
2 years
Title
Patient self rating of quality of life T0
Description
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Time Frame
baseline
Title
Patient self rating of quality of life T12
Description
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Time Frame
1 year
Title
Patient self rating of quality of life T24
Description
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Time Frame
2 years
Title
Psychotic symptoms T0
Description
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Time Frame
baseline
Title
Psychotic symptoms T12
Description
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Time Frame
1 year
Title
Depression T0
Description
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Time Frame
baseline
Title
Depression T12
Description
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Time Frame
1 year
Title
Clinical outcome T0: Clinically significant events
Description
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Time Frame
baseline
Title
Clinical outcome T12: Clinically significant events
Description
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Time Frame
1 year
Title
Patient self rating of recovery T0
Description
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Time Frame
baseline
Title
Patient self rating of recovery T12
Description
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Time Frame
1 year
Title
Patient self rating of recovery T24
Description
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Professional's Recovery knowledge on patients T0
Description
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Time Frame
baseline
Title
Professional's Recovery knowledge on patients T12
Description
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Time Frame
1 year
Title
Professional's Recovery opinions on patients T0
Description
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Time Frame
baseline
Title
Professional's Recovery opinions on patients T12
Description
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Time Frame
1 year
Title
Stigmatization T0
Description
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Time Frame
baseline
Title
Stigmatization T12
Description
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Time Frame
1 year
Title
Perceived needs T0
Description
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Time Frame
baseline
Title
Perceived needs T12
Description
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Time Frame
1 year
Title
Goal achievement T12
Description
Goal achievement scale (GAS), range -2 to +2, higher values correspond to better achievement of one specific goal
Time Frame
1 year
Title
Metacognitive strategies T0
Description
Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies
Time Frame
baseline
Title
Sleep T0
Description
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Time Frame
baseline
Title
Sleep T12
Description
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Time Frame
1 year
Title
Medication adherence T0
Description
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Time Frame
baseline
Title
Medication adherence T12
Description
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Time Frame
1 year
Title
Illness severity T0
Description
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Time Frame
baseline
Title
Illness severity T12
Description
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Time Frame
1 year
Title
Cognitive disability T0
Description
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Time Frame
baseline
Title
Cognitive disability T12
Description
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Time Frame
1 year
Title
Entourage assessment of structure recovery orientation T0
Description
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation
Time Frame
baseline
Title
Entourage assessment of structure recovery orientation T12
Description
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Structure recovery orientation T0
Description
Recovery Self-Assessment Services (RSA-R Services), range 32-160, higher values correspond to more pronounced recovery orientation of the structure
Time Frame
baseline
Title
Structure recovery orientation T24
Description
Recovery Self-Assessment Services (RSA-R Services), range 32-160, higher values correspond to more pronounced recovery orientation of the structure
Time Frame
2 years
Title
Implementation fidelity T0
Description
Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation
Time Frame
baseline
Title
Implementation fidelity T24
Description
Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of a severe and persistent mental disorder among the following ICD10 compliant diagnostic categories: Schizophrenia spectrum disorder (F2x) Recurrent or persistent mood disorders (F30.x, F31.x, F33.x, F34.x, F38.x) Psychological developmental disorders including autism spectrum disorders (F8x) and childhood and adolescent onset disorders (F9x) Presence of an indication for inclusion in the rehabilitation project identified by the treating psychiatrist and endorsed in the inclusion session by the PASSVers staff. Written consent from the patient or his/her legal representative to participate in the study. Exclusion Criteria: Presence of an not stabilized or progressive organic neurological pathology, neurodegenerative disease Psychological or behavioral disorders mainly related to addictions with substances Psychiatric disorders secondary to an organic pathology that is not stabilized or that is evolving The following psychiatric situations are reasons for non-inclusion in the absence of an argued and collegial reassessment (the reason being that, although PASSVers2 must be considered as a first intention proposal in many situations meeting the inclusion criteria, it cannot intervene or be thought of as a "solution" to certain complex situations): Psychiatric disorders caused by pregnancy or immediate postpartum Severe borderline personality disorder Current suicidal crisis Extreme fragility of the patient with respect to changes that may be induced by the project, associated with a high risk of self or hetero-aggression. Patient under justice constraint Foreseeable departure from the geographic area, not allowing for certainty of further evaluation Refusal of the patient to be followed by a social-health team (i.e. refusal of care or refusal of a dialogue on social aspects and projects).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie Bulot, MD
Phone
33 1 39 63 90 11
Email
vbulot@ch-versailles.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Brunet-Gouet, MD PhD
Email
ebrunet@ch-versailles.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Passerieux, Prof
Organizational Affiliation
CH Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
City
Argenteuil
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Lamisse, MD
Facility Name
Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr de Maricourt, MD
Facility Name
Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
City
Rambouillet
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Omnès, MD
Facility Name
Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
City
Rueil-Malmaison
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Matthieu, MD
Facility Name
Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles
City
Versailles
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Bratu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).
Results Reference
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Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area

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