Status:
NOT_YET_RECRUITING
Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area
Lead Sponsor:
Versailles Hospital
Collaborating Sponsors:
Agence régionale de santé Ile de France
UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
Conditions:
Severe Mental Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 inte...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05274126
Start Date
May 1 2022
End Date
May 1 2026
Last Update
March 25 2022
Active Locations (5)
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1
Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
Argenteuil, France
2
Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
Paris, France
3
Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
Rambouillet, France
4
Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
Rueil-Malmaison, France