Clinical trial NCT04025905: Social Cognition Training and Vocational Rehabilitation
Official title: REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant is randomized in one of the two groups, defined by the type of treatment allocated: Social Cognition Training program or only Informations
Primary purpose: OTHER

Brief summary: Social cognition impairments, frequently encountered in Serial Mental Illness, reduce the ability to find and to keep a job. Cognitive remediation and social cognition training reduce the impact of cognitive impairments on work outcomes . The purpose of this research is to associate a social cognition training program to vocational rehabilitation in the transition network (transitional Workforce Assistance Facilities and Services) to help people to maintain their jobs and to access to work in an ordinary environment. To support the development of social cognition interventions, additional care (users will retain their usual medical follow-up) will be implemented within the Workforce Assistance Facilities and Services.

This project is part of a strong partnership between the Cognitive remediation network (health sector: rehabilitation centers) and the Transition network (medico-social sector: three Workforce Assistance Facilities and Services having partnerships with rehabilitation centers). This partnership has been experienced previously in the RemedRehab project funded by the 2012 hospital clinical research program (PHRC). This project was recently completed.

Detailed description: Social cognition training concomitant to work help to maintain employment in transitional Workforce Assistance Facilities and Services .

Participation in the study will be offered to anyone with severe psychic disorders and a social cognition disorder who started working in one of the transitional Workforce Assistance Facilities and Services in the year prior to inclusion to limit selection bias.

The study population is defined by the transitional Workforce Assistance Facilities and Services users involved.

The diagnosis is not included in the inclusion criteria. It will, however, be established according to DSM-5 criteria for included users, who will benefit from a semi-structured interview .

The expected benefits in the social cognition training programgroup are: best job maintaining rate in transitional Workforce Assistance Facilities and Services , improvement of social cognition, improvement of interpersonal skills, improvement of self-esteem, improvement of professional insertion and improvement of the patient's vision of his place in society.

Participants enrolled in information group may expect benefits on socialization and empowerment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a serious mental illness (The specific diagnosis is not included in the inclusion criteria. It will, however, be established according to DSM-5 criteria for included users, who will benefit from a semi-structured interview (MINI, Sheehan et al., 1998).
* Admission in an ESAT in the last year prior to enrollment
* Expected duration of employment beyond two years
* Tutor's agreement (for persons under tutorship)
* Affiliation to social insurance

Exclusion Criteria:

* Absence of a social cognition disorder at neuropsychological evaluations
* Simultaneous participation in a social cognition remediation program
* Insufficient level of understanding of French to participate in the group (verbal exchanges)
* Insufficient visual acuity to participate in the group (use of slideshow in the group sessions)

Primary outcomes:
measure: Change from baseline in total number of hours worked
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in social cognitive
timeFrame: 6 months
measure: Change from baseline in self-esteem
timeFrame: 6 months
measure: Change from baseline in self-stigmatization
timeFrame: 6 months
measure: Change from baseline in the recovery process
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: centre de réhabilitation - Hôpital le Vinatier
state: Rhône
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: FRANCK NICOLAS, PhD
role: PRINCIPAL_INVESTIGATOR
References: