Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area

Severe Mental Disorder Clinical Trial

— PASSVERS-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05274126
• Other study ID #: P20/03_ PASSVERS-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2022
• Source: Versailles Hospital
• Contact: Virginie Bulot, MD
• Phone: 33 1 39 63 90 11
• Email: vbulot[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mental Disorders
• Severe Mental Disorder

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Versailles Hospital	Agence régionale de santé Ile de France, UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Implementation fidelity T0	Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation	baseline
Other	Implementation fidelity T24	Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Patient functioning T0	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	baseline
Primary	Patient functioning T12	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	1 year
Primary	Patient functioning T24	Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning	2 years
Primary	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
Primary	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
Primary	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
Primary	Psychotic symptoms T0	Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels	baseline
Primary	Psychotic symptoms T12	Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels	1 year
Primary	Depression T0	Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms	baseline
Primary	Depression T12	Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Professional's Recovery knowledge on patients T0	Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Stigmatization T0	Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception	baseline
Secondary	Stigmatization T12	Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception	1 year
Secondary	Perceived needs T0	Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help	baseline
Secondary	Perceived needs T12	Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help	1 year
Secondary	Goal achievement T12	Goal achievement scale (GAS), range -2 to +2, higher values correspond to better achievement of one specific goal	1 year
Secondary	Metacognitive strategies T0	Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies	baseline
Secondary	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
Secondary	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
Secondary	Medication adherence T0	Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment	baseline
Secondary	Medication adherence T12	Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment	1 year
Secondary	Illness severity T0	Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness	baseline
Secondary	Illness severity T12	Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness	1 year
Secondary	Cognitive disability T0	Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning	baseline
Secondary	Cognitive disability T12	Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning	1 year
Secondary	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
Secondary	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