SchizophreniaREMEDEMPLOINCT04025905
Social Cognition Training and Vocational Rehabilitation
A study testing Social Cognition Training and Informations in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social Cognition Training and Informations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2020to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Social Cognition Training, Informations
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition TrainingBehavioural
Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.
InformationsBehavioural
informations about work environment, social environment, stress management, sleep management, treatments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Informations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Change from baseline in social cognitive
The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start14 Feb 2020
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCK NICOLAS, PhD, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025905
- Sponsor's protocol ID
- 2019-A00124-53
- Acronym
- REMEDEMPLOI
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2019
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation
- ClinicalTrials.gov ID
- NCT04025905
- Acronym / sponsor ID
- REMEDEMPLOI / 2019-A00124-53
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Social Cognition Training Program | Experimental | Behavioral: Social Cognition TrainingThis 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 |
| Informations program | Sham comparator | Behavioral: InformationsEducational 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition TrainingEvaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services. | Behavioural | Social Cognition Training Program |
| Informationsinformations about work environment, social environment, stress management, sleep management, treatments | Behavioural | Informations program |
Primary outcome
Change from baseline in total number of hours worked
Time frame: 6 months
Difference between the total number of hours worked compared to the number of working hours provided for in the work contract for 6 months
4 secondary outcomes
Change from baseline in social cognitive
Time frame: 6 months
Change from baseline in self-esteem
Time frame: 6 months
Change from baseline in self-stigmatization
Time frame: 6 months
Change from baseline in the recovery process
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FRANCK NICOLAS, PhD principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition Training and Informations in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total number of hours worked (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.