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

Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)

Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Mental Disorder
• Intervention / Treatment: Behavioral: Patient group/Passvers

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginie Bulot, MD; Phone Number: 33 1 39 63 90 11; Email: vbulot@ch-versailles.fr
• Study Contact Backup: Name: Eric Brunet-Gouet, MD PhD; Email: ebrunet@ch-versailles.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient group (single group); 300 Patients involved in the recovery process.

Behavioral: Patient group/Passvers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline
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	1 year
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	baseline
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	1 year
Patient functioning T0	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	baseline
Patient functioning T12	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	1 year
Patient functioning T24	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	2 years
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	baseline
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	1 year
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	2 years
Psychotic symptoms T0	Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels	baseline
Psychotic symptoms T12	Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels	1 year
Depression T0	Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms	baseline
Depression T12	Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms	1 year
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	baseline
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	1 year
Patient self rating of recovery T0	Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery	baseline
Patient self rating of recovery T12	Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery	1 year
Patient self rating of recovery T24	Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional's Recovery knowledge on patients T0	Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes	baseline
Professional's Recovery knowledge on patients T12	Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes	1 year
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	baseline
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	1 year
Stigmatization T0	Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception	baseline
Stigmatization T12	Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception	1 year
Perceived needs T0	Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help	baseline
Perceived needs T12	Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help	1 year
Goal achievement T12	Goal achievement scale (GAS), range -2 to +2, higher values correspond to better achievement of one specific goal	1 year
Metacognitive strategies T0	Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies	baseline
Sleep T0	Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality	baseline
Sleep T12	Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality	1 year
Medication adherence T0	Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment	baseline
Medication adherence T12	Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment	1 year
Illness severity T0	Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness	baseline
Illness severity T12	Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness	1 year
Cognitive disability T0	Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning	baseline
Cognitive disability T12	Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning	1 year
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	baseline
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	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structure recovery orientation T0	Recovery Self-Assessment Services (RSA-R Services), range 32-160, higher values correspond to more pronounced recovery orientation of the structure	baseline
Structure recovery orientation T24	Recovery Self-Assessment Services (RSA-R Services), range 32-160, higher values correspond to more pronounced recovery orientation of the structure	2 years
Implementation fidelity T0	Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation	baseline
Implementation fidelity T24	Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation	2 years

Collaborators and Investigators

• Sponsor: Versailles Hospital
• Collaborators: Agence régionale de santé Ile de France; UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
• Investigators: Principal Investigator: Christine Passerieux, Prof, CH Versailles

Publications and helpful links

General Publications

• Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Autism; Bipolar disorder
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: P20/03_ PASSVERS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No