Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06622993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3', 'timeFrame': 'At the randomisation and Month 3'}], 'secondaryOutcomes': [{'measure': 'Evolution of Transdiagnostic Skills Scale (T2S) score', 'timeFrame': 'At randomisation, Month 3 and Month 6'}, {'measure': 'Evolution of Symptomatic Transdiagnostic Test (S2T) score', 'timeFrame': 'At randomisation, Month 3 and Month 6'}, {'measure': 'Evolution of Hosptital Anxiety Depression Scalre (HADS) score', 'timeFrame': 'At randomisation, Month 3 and Month 6'}, {'measure': 'Evolution of Satisfaction with Life Scale (SWLS) score', 'timeFrame': 'At randomisation, Month 3 and Month 6'}, {'measure': 'Cumulative quantity of psychotropic treatment taken by patients (in mg)', 'timeFrame': 'At randomisation, Month 3 and Month 6'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychiatric Disorders']}, 'descriptionModule': {'briefSummary': 'Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.\n\nThe management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Have at least one diagnosis of a psychiatric disorder\n* Be able to carry out psychotherapy sessions\n* Have been on stable psychiatric medication for 30 days\n* Written informed consent obtained from the participant\n* Be affiliated to a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.\n* Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship\n* Presence of a severe depressive episode\n* Be engaged in psychotherapeutic work elsewhere\n* Presence of a state of excessive deficit, making psychotherapy impossible\n* Presence of psychic decompensation (e.g. delusions) making psychotherapy impossible'}, 'identificationModule': {'nctId': 'NCT06622993', 'acronym': 'P-SKILLS', 'briefTitle': 'Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DR240057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Programm SKILLS', 'interventionNames': ['Other: Psychotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list'}], 'interventions': [{'name': 'Psychotherapy', 'type': 'OTHER', 'description': 'The experimental group will receive the SKILLS program, i.e. 10 group psychotherapy sessions.', 'armGroupLabels': ['Programm SKILLS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'VANCAPPEL', 'role': 'CONTACT', 'email': 'alexis.vancappel@univ-tours.fr', 'phone': '+33247477111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}