Social Cognition Training and Vocational Rehabilitation (REMEDEMPLOI)

REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Social Cognition Training; Behavioral: Informations

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône
    • Lyon, Rhône, France, 69006
      • centre de réhabilitation - Hôpital le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Cognition Training Program; 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; Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.
Sham Comparator: Informations program; 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; informations about work environment, social environment, stress management, sleep management, treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in social cognitive	The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia	6 months
Change from baseline in self-esteem	Self-Esteem Rating Scale - Short Form (SERS-SF). Self-esteem was assessed with the Self-Esteem Rating Scale-Short Form (SERS-SF) . The SERS is a 20-item self-rating scale with two subscales: positive and negative self-esteem.	6 months
Change from baseline in self-stigmatization	Internalized Stigma of Mental Illness scale (ISMI ). The ISMI scale was developed to measure the internalized stigma of people with a mental illness	6 months
Change from baseline in the recovery process	STages Of Recovery Instrument (STORI) The STORI consists of 50 items, presented in 10 groups of five. Each group represents one of the four process components of recovery: hope; identity; meaning; responsibility	6 months

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: FRANCK NICOLAS, PhD, Centre Hospitalier le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 2019-A00124-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No