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Social Cognition Training and Vocational Rehabilitation (REMEDEMPLOI)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Social Cognition Training
Informations
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • centre de réhabilitation - Hôpital le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Social Cognition Training Program

Informations program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in social cognitive
The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia
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.
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
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

Full Information

First Posted
July 17, 2019
Last Updated
March 15, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04025905
Brief Title
Social Cognition Training and Vocational Rehabilitation
Acronym
REMEDEMPLOI
Official Title
REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
February 14, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Cognition Training Program
Arm Type
Experimental
Arm Description
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
Arm Title
Informations program
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition Training
Intervention Description
Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.
Intervention Type
Behavioral
Intervention Name(s)
Informations
Intervention Description
informations about work environment, social environment, stress management, sleep management, treatments
Primary Outcome Measure Information:
Title
Change from baseline in total number of hours worked
Description
Difference between the total number of hours worked compared to the number of working hours provided for in the work contract for 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in social cognitive
Description
The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia
Time Frame
6 months
Title
Change from baseline in self-esteem
Description
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.
Time Frame
6 months
Title
Change from baseline in self-stigmatization
Description
Internalized Stigma of Mental Illness scale (ISMI ). The ISMI scale was developed to measure the internalized stigma of people with a mental illness
Time Frame
6 months
Title
Change from baseline in the recovery process
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FRANCK NICOLAS, PhD
Phone
0033426738533
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
CERVELLO SOPHIE, MD
Phone
0033426738533
Email
sophie.cervello@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK NICOLAS, PhD
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de réhabilitation - Hôpital le Vinatier
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Nicolas, PUPH
Phone
+33 (0)4 26 23 76 11
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Veronique VIAL
Phone
+33 (0)4 37915531
Email
veronique.vial@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Franck Nicolas

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Cognition Training and Vocational Rehabilitation

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