Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT04025905
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Cognition Training and Vocational Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each participant is randomized in one of the two groups, defined by the type of treatment allocated: Social Cognition Training program or only Informations'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in total number of hours worked', 'timeFrame': '6 months', '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'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in social cognitive', 'timeFrame': '6 months', 'description': 'The Ambiguous Intentions Hostility Questionnaire (AIHQ): a measure for evaluating hostile social-cognitive biases in paranoia'}, {'measure': 'Change from baseline in self-esteem', 'timeFrame': '6 months', '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.'}, {'measure': 'Change from baseline in self-stigmatization', 'timeFrame': '6 months', 'description': 'Internalized Stigma of Mental Illness scale (ISMI ). The ISMI scale was developed to measure the internalized stigma of people with a mental illness'}, {'measure': 'Change from baseline in the recovery process', 'timeFrame': '6 months', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': "Social cognition training concomitant to work help to maintain employment in transitional Workforce Assistance Facilities and Services .\n\nParticipation 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.\n\nThe study population is defined by the transitional Workforce Assistance Facilities and Services users involved.\n\nThe 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 .\n\nThe 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.\n\nParticipants enrolled in information group may expect benefits on socialization and empowerment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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).\n* Admission in an ESAT in the last year prior to enrollment\n* Expected duration of employment beyond two years\n* Tutor's agreement (for persons under tutorship)\n* Affiliation to social insurance\n\nExclusion Criteria:\n\n* Absence of a social cognition disorder at neuropsychological evaluations\n* Simultaneous participation in a social cognition remediation program\n* Insufficient level of understanding of French to participate in the group (verbal exchanges)\n* Insufficient visual acuity to participate in the group (use of slideshow in the group sessions)"}, 'identificationModule': {'nctId': 'NCT04025905', 'acronym': 'REMEDEMPLOI', 'briefTitle': 'Social Cognition Training and Vocational Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation', 'orgStudyIdInfo': {'id': '2019-A00124-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Cognition Training Program', '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', 'interventionNames': ['Behavioral: Social Cognition Training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Informations program', '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.', 'interventionNames': ['Behavioral: Informations']}], 'interventions': [{'name': 'Social Cognition Training', 'type': 'BEHAVIORAL', 'description': 'Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.', 'armGroupLabels': ['Social Cognition Training Program']}, {'name': 'Informations', 'type': 'BEHAVIORAL', 'description': 'informations about work environment, social environment, stress management, sleep management, treatments', 'armGroupLabels': ['Informations program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69006', 'city': 'Lyon', 'state': 'Rhône', 'country': 'France', 'facility': 'centre de réhabilitation - Hôpital le Vinatier', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'FRANCK NICOLAS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Vinatier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}