Social Cognition Training and Vocational Rehabilitation

Schizophrenia Clinical Trial

— REMEDEMPLOI  

Official title:

REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025905
• Other study ID #: 2019-A00124-53
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: June 15, 2025

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: FRANCK NICOLAS, PhD
• Phone: 0033426738533
• Email: nicolas.franck[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 15, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Social Cognition Training
Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.
• Informations
informations about work environment, social environment, stress management, sleep management, treatments

Locations

Country	Name	City	State
France	centre de réhabilitation - Hôpital le Vinatier	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in social cognitive	The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia	6 months
Secondary	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
Secondary	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
Secondary	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