NCT05274126

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

February 15, 2022

Last Update Submit

March 24, 2022

Conditions

Severe Mental Disorder

Keywords

SchizophreniaBipolar disorderAutism

Outcome Measures

Primary Outcomes (19)

  • 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 Outcomes (20)

  • Professional's Recovery knowledge on patients T0

    baseline

  • Professional's Recovery knowledge on patients T12

    1 year

  • Professional's Recovery opinions on patients T0

    baseline

  • Professional's Recovery opinions on patients T12

    1 year

  • Stigmatization T0

    baseline

  • +15 more secondary outcomes

Other Outcomes (4)

  • Structure recovery orientation T0

    baseline

  • Structure recovery orientation T24

    2 years

  • Implementation fidelity T0

    baseline

  • +1 more other outcomes

Study Arms (1)

Patient group (single group)

EXPERIMENTAL

300 Patients involved in the recovery process.

Behavioral: Patient group/Passvers

Interventions

Patient group/PassversBEHAVIORAL

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.

Patient group (single group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Written consent from the patient or his/her legal representative to participate in the study.

You may not qualify if:

  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,

Argenteuil, France

Location

Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015

Paris, France

Location

Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet

Rambouillet, France

Location

Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison

Rueil-Malmaison, France

Location

Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles

Versailles, France

Location

Related 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).

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersSchizophreniaBipolar DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental Disorders

Study Officials

  • Christine Passerieux, Prof

    CH Versailles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie Bulot, MD

CONTACT

33 1 39 63 90 11vbulot@ch-versailles.fr

Eric Brunet-Gouet, MD PhD

CONTACT

ebrunet@ch-versailles.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 10, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2026

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)