Social Cognition Training and Vocational Rehabilitation

NCT04025905 | Completed

• 1 other identifier: 2019-A00124-53
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total number of hours worked

  Difference between the total number of hours worked compared to the number of working hours provided for in the work contract for 6 months

  6 months

Secondary Outcomes (4)

• Change from baseline in social cognitive

  6 months

• Change from baseline in self-esteem

  6 months

• Change from baseline in self-stigmatization

  6 months

• Change from baseline in the recovery process

  6 months

Study Arms (2)

Social Cognition Training Program

EXPERIMENTAL

This program is taken from two validated cognitive remediation programs: the SCIT program and the RC2S program : perception of social situations - emotional processes and social perception;interpretation of social situations - theory of mind and attributions;acting in social situations - social skills training

Behavioral: Social Cognition Training

Informations program

SHAM COMPARATOR

Educational team Information will be given to participants about work environment, social environment, stress management, sleep management, treatments. It will also include socialization sessions with board games or cultural activities.

Behavioral: Informations

Interventions

Social Cognition Training BEHAVIORAL

Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.

Social Cognition Training Program

Informations BEHAVIORAL

informations about work environment, social environment, stress management, sleep management, treatments

Informations program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• FRANCK NICOLAS, PhD

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will be stratified by site, and history of previous work in supported employment (≥ 1 year working in the ESAT prior to enrollment) so that each treatment is implemented in 3 groups of 10 people in each of the three centers.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant is randomized in one of the two groups, defined by the type of treatment allocated: Social Cognition Training program or only Informations

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: February 14, 2020
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)