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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)

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ClinicalTrials.gov Identifier: NCT05274126
Recruitment Status : Not yet recruiting
First Posted : March 10, 2022
Last Update Posted : March 25, 2022
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Mental Disorder Behavioral: Patient group/Passvers Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Patient functioning T0 [ Time Frame: baseline ]
    Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning

  6. Patient functioning T12 [ Time Frame: 1 year ]
    Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning

  7. Patient functioning T24 [ Time Frame: 2 years ]
    Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning

  8. 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

  9. 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

  10. 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

  11. Psychotic symptoms T0 [ Time Frame: baseline ]
    Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels

  12. Psychotic symptoms T12 [ Time Frame: 1 year ]
    Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels

  13. Depression T0 [ Time Frame: baseline ]
    Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms

  14. Depression T12 [ Time Frame: 1 year ]
    Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Stigmatization T0 [ Time Frame: baseline ]
    Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception

  6. Stigmatization T12 [ Time Frame: 1 year ]
    Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception

  7. Perceived needs T0 [ Time Frame: baseline ]
    Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help

  8. Perceived needs T12 [ Time Frame: 1 year ]
    Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help

  9. 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

  10. Metacognitive strategies T0 [ Time Frame: baseline ]
    Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies

  11. 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

  12. 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

  13. Medication adherence T0 [ Time Frame: baseline ]
    Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment

  14. Medication adherence T12 [ Time Frame: 1 year ]
    Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment

  15. Illness severity T0 [ Time Frame: baseline ]
    Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness

  16. Illness severity T12 [ Time Frame: 1 year ]
    Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness

  17. 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

  18. 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

  19. 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

  20. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. Implementation fidelity T0 [ Time Frame: baseline ]
    Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation

  4. Implementation fidelity T24 [ Time Frame: 2 years ]
    Professional ratings of Passvers fidelity scale, range 0-92, higher values correspond to better implementation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05274126


Contacts
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Contact: Virginie Bulot, MD 33 1 39 63 90 11 vbulot@ch-versailles.fr
Contact: Eric Brunet-Gouet, MD PhD ebrunet@ch-versailles.fr

Locations
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France
Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
Argenteuil, France
Contact: Dr Lamisse, MD         
Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
Paris, France
Contact: Dr de Maricourt, MD         
Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
Rambouillet, France
Contact: Dr Omnès, MD         
Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
Rueil-Malmaison, France
Contact: Dr Matthieu, MD         
Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles
Versailles, France
Contact: Dr Bratu, MD         
Sponsors and Collaborators
Versailles Hospital
Agence régionale de santé Ile de France
UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
Investigators
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Principal Investigator: Christine Passerieux, Prof CH Versailles
More Information
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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).

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Responsible Party: Dr Christine PASSERIEUX, Principal Investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT05274126    
Other Study ID Numbers: P20/03_ PASSVERS-2
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Christine PASSERIEUX, Versailles Hospital:
Schizophrenia
Bipolar disorder
Autism
Additional relevant MeSH terms:
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Mental Disorders