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Clinical Trials/NCT05274126
NCT05274126
Not Yet Recruiting
N/A

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

Versailles Hospital5 sites in 1 country300 target enrollmentMay 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Mental Disorder
Sponsor
Versailles Hospital
Enrollment
300
Locations
5
Primary Endpoint
Patient self rating of recovery support by caregivers T12
Status
Not Yet Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
May 1, 2026
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Christine PASSERIEUX

Principal Investigator

Versailles Hospital

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

Outcomes

Primary Outcomes

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 T12

Time Frame: 1 year

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 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 and structure T0

Time Frame: baseline

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

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 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

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

Patient functioning T12

Time Frame: 1 year

Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning

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 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

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 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 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

Depression T0

Time Frame: baseline

Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms

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

Secondary Outcomes

  • Perceived needs T0(baseline)
  • Sleep T0(baseline)
  • Professional's Recovery opinions on patients T12(1 year)
  • Stigmatization T0(baseline)
  • Perceived needs T12(1 year)
  • Cognitive disability T0(baseline)
  • Professional's Recovery knowledge on patients T12(1 year)
  • Professional's Recovery opinions on patients T0(baseline)
  • Goal achievement T12(1 year)
  • Metacognitive strategies T0(baseline)
  • Entourage assessment of structure recovery orientation T0(baseline)
  • Stigmatization T12(1 year)
  • Sleep T12(1 year)
  • Medication adherence T12(1 year)
  • Illness severity T0(baseline)
  • Illness severity T12(1 year)
  • Entourage assessment of structure recovery orientation T12(1 year)
  • Professional's Recovery knowledge on patients T0(baseline)
  • Medication adherence T0(baseline)
  • Cognitive disability T12(1 year)

Study Sites (5)

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