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

Versailles Hospital

Status: Not yet enrolling

Conditions: Severe Mental Disorder

Treatments: Behavioral: Patient group/Passvers

Study type: Interventional

Funder types: Other

Identifiers

NCT05274126

P20/03_ PASSVERS-2

Details and patient eligibility

About

Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Patient group (single group)

Experimental group

Description:

300 Patients involved in the recovery process.

Treatment:

Behavioral: Patient group/Passvers