Social Cognition Training and Vocational Rehabilitation

NCT ID: NCT04025905

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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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

Group Type EXPERIMENTAL

Social Cognition Training

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

Informations

Intervention Type BEHAVIORAL

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

Interventions

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Social Cognition Training

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

Intervention Type BEHAVIORAL

Informations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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FRANCK NICOLAS, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

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centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, France

Site Status

Countries

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France

Other Identifiers

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2019-A00124-53

Identifier Type: -

Identifier Source: org_study_id

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