Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT04850066
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social adjustment (self reported)', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in the score of the SAS-SR (social adjustment scale -self report) (from 1 (excellent adjustment) to 5 (bad adjustment))'}, {'measure': 'Social adjustment', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in the score of the SAS (social adjustment scale) (from 1 (excellent adjustment) to 5 (bad adjustment))'}], 'secondaryOutcomes': [{'measure': 'Assertiveness', 'timeFrame': 'Baseline, 2 and 6 months', 'description': 'Change in the score of the Rathus assertiveness schedule (from -90 (difficulties of assertivity) to +90 (good assertivity))'}, {'measure': 'Self-esteem', 'timeFrame': 'Baseline, 2 and 6 months', 'description': "Change in the score of the Rosenberg's Self-Esteem scale (from 10 to 40)."}, {'measure': 'Ways of coping', 'timeFrame': 'Baseline, 2 and 6 months', 'description': 'Change in the score of the Ways of coping checklist (from 27 to 108).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychiatry', 'Psychosocial adjustment'], 'conditions': ['Equine-assisted Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of a brief equine-assisted intervention on the social adjustment, assertiveness, self-esteem and coping strategies in adult patients with psychosocial dysfunction, hospitalized and followed in psychiatry, as compared to standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients hospitalized in psychiatry with mental disorders lasting for more than 6 months with an EGF score on the Global Evaluation of Psychosocial Functioning scale of between 31 and 60 at the time of inclusion.\n\nExclusion Criteria:\n\n* acute psychiatric crisis\n* severe comorbidities (such as mental retardation, mental deterioration) which could invalidate informed consent or limit patient compliance with the study protocol.\n* medical contraindication to equine-assisted therapy (allergy, immunocompromised patients)\n* pregnancy\n* no affiliation to a social security scheme\n* deprivation of liberty by a judicial decision\n* wardship\n* horse phobia'}, 'identificationModule': {'nctId': 'NCT04850066', 'acronym': 'PEGASE', 'briefTitle': 'Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Dreux'}, 'officialTitle': 'Evaluation of the Efficacy of an Equine-assisted Intervention on the Psychosocial Adjustment of Adult Patients Hospitalized and Monitored in Psychiatry: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2018-A00022-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Equine-assisted intervention', 'description': 'Brief program (3 sessions)', 'interventionNames': ['Behavioral: Equine-assisted intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care with treatments as usual'}], 'interventions': [{'name': 'Equine-assisted intervention', 'type': 'BEHAVIORAL', 'description': 'Usual care including an equine-assisted intervention carried out on foot, next to the horse, in 3 sessions of 3 hours each, spread over 4 weeks. This program is based on self-awareness, communication, assertiveness and adaptability.', 'armGroupLabels': ['Equine-assisted intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Dreux', 'country': 'France', 'facility': 'Centre Hospitalier Victor Jousselin', 'geoPoint': {'lat': 48.73649, 'lon': 1.36566}}], 'overallOfficials': [{'name': 'Pierre-Charles PARIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Santé Mentale - Centre Hospitalier de Dreux'}, {'name': 'Anne HERON', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unité de Recherche Clinique ARC en CIEL - Centre Hospitalier de Dreux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Dreux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}