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

• ClinicalTrials.gov Identifier: NCT05274126
• Recruitment Status: Not yet recruiting
• First Posted: March 10, 2022
• Last Update Posted: March 25, 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
• Information provided by (Responsible Party): Dr Christine PASSERIEUX, Versailles Hospital

Tracking Information

• First Submitted Date: February 15, 2022
• First Posted Date: March 10, 2022
• Last Update Posted Date: March 25, 2022
• Estimated Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2022)

• Patient self rating of recovery support by caregivers T0 [ Time Frame: baseline ]
  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 [ Time Frame: 1 year ]
  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 [ Time Frame: baseline ]
  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 [ Time Frame: 1 year ]
  Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
• Patient functioning T0 [ Time Frame: baseline ]
  Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
• Patient functioning T12 [ Time Frame: 1 year ]
  Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
• Patient functioning T24 [ Time Frame: 2 years ]
  Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
• Patient self rating of quality of life T0 [ Time Frame: baseline ]
  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 [ Time Frame: 1 year ]
  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 [ Time Frame: 2 years ]
  Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
• Psychotic symptoms T0 [ Time Frame: baseline ]
  Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
• Psychotic symptoms T12 [ Time Frame: 1 year ]
  Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
• Depression T0 [ Time Frame: baseline ]
  Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
• Depression T12 [ Time Frame: 1 year ]
  Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
• Clinical outcome T0: Clinically significant events [ Time Frame: baseline ]
  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 [ Time Frame: 1 year ]
  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 [ Time Frame: baseline ]
  Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
• Patient self rating of recovery T12 [ Time Frame: 1 year ]
  Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
• Patient self rating of recovery T24 [ Time Frame: 2 years ]
  Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 1, 2022)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 1, 2022)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area
• Official Title: Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: 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.

Study Arms

Experimental: Patient group (single group)

300 Patients involved in the recovery process.

Intervention: Behavioral: Patient group/Passvers

• 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).

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 1, 2022): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2026
• Estimated Primary Completion Date: May 1, 2025 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Virginie Bulot, MD; 33 1 39 63 90 11; vbulot@ch-versailles.fr

Contact: Eric Brunet-Gouet, MD PhD; ebrunet@ch-versailles.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05274126
• Other Study ID Numbers: P20/03_ PASSVERS-2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr Christine PASSERIEUX, Versailles Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Versailles Hospital
• Original Study Sponsor: Same as current

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

• PRS Account: Versailles Hospital
• Verification Date: March 2022