Clinical trial NCT05274126: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Keywords: Schizophrenia
Bipolar disorder
Autism
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Agence régionale de santé Ile de France
name: UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
First posted: 2022-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Patient self rating of recovery support by caregivers T0
timeFrame: baseline
measure: Patient self rating of recovery support by caregivers T12
timeFrame: 1 year
measure: Patient self rating of recovery support by caregivers and structure T0
timeFrame: baseline
measure: Patient self rating of recovery support by caregivers and structure T12
timeFrame: 1 year
measure: Patient functioning T0
timeFrame: baseline
measure: Patient functioning T12
timeFrame: 1 year
measure: Patient functioning T24
timeFrame: 2 years
measure: Patient self rating of quality of life T0
timeFrame: baseline
measure: Patient self rating of quality of life T12
timeFrame: 1 year
measure: Patient self rating of quality of life T24
timeFrame: 2 years
measure: Psychotic symptoms T0
timeFrame: baseline
measure: Psychotic symptoms T12
timeFrame: 1 year
measure: Depression T0
timeFrame: baseline
measure: Depression T12
timeFrame: 1 year
measure: Clinical outcome T0: Clinically significant events
timeFrame: baseline
measure: Clinical outcome T12: Clinically significant events
timeFrame: 1 year
measure: Patient self rating of recovery T0
timeFrame: baseline
measure: Patient self rating of recovery T12
timeFrame: 1 year
measure: Patient self rating of recovery T24
timeFrame: 2 years
Secondary outcomes:
measure: Professional's Recovery knowledge on patients T0
timeFrame: baseline
measure: Professional's Recovery knowledge on patients T12
timeFrame: 1 year
measure: Professional's Recovery opinions on patients T0
timeFrame: baseline
measure: Professional's Recovery opinions on patients T12
timeFrame: 1 year
measure: Stigmatization T0
timeFrame: baseline
measure: Stigmatization T12
timeFrame: 1 year
measure: Perceived needs T0
timeFrame: baseline
measure: Perceived needs T12
timeFrame: 1 year
measure: Goal achievement T12
timeFrame: 1 year
measure: Metacognitive strategies T0
timeFrame: baseline
measure: Sleep T0
timeFrame: baseline
measure: Sleep T12
timeFrame: 1 year
measure: Medication adherence T0
timeFrame: baseline
measure: Medication adherence T12
timeFrame: 1 year
measure: Illness severity T0
timeFrame: baseline
measure: Illness severity T12
timeFrame: 1 year
measure: Cognitive disability T0
timeFrame: baseline
measure: Cognitive disability T12
timeFrame: 1 year
measure: Entourage assessment of structure recovery orientation T0
timeFrame: baseline
measure: Entourage assessment of structure recovery orientation T12
timeFrame: 1 year
Other outcomes:
measure: Structure recovery orientation T0
timeFrame: baseline
measure: Structure recovery orientation T24
timeFrame: 2 years
measure: Implementation fidelity T0
timeFrame: baseline
measure: Implementation fidelity T24
timeFrame: 2 years
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
city: Paris
country: France
facility: Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
city: Rambouillet
country: France
facility: Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
city: Rueil-Malmaison
country: France
facility: Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
city: Versailles
country: France
facility: Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles
Study officials:
affiliation: CH Versailles
name: Christine Passerieux, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).