Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-27 @ 11:05 AM
Study NCT ID:
NCT05727358
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2023-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)', 'timeFrame': 'immediately after the intervention', 'description': 'Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression'}, {'measure': 'The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)', 'timeFrame': '3 months after the intervention', 'description': 'Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': 'immediately after and 3 months after the intervention', 'description': 'physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL'}, {'measure': 'The Acceptance and Action Questionnaire II (AAQ-II)', 'timeFrame': 'immediately after and 3 months after the intervention', 'description': 'the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility.'}, {'measure': 'The Cognitive Fusion Questionnaire (CFQ)', 'timeFrame': 'immediately after and 3 months after the intervention', 'description': "scores range from 0 to 63 with a higher score indicating more fused one is with one's thoughts"}, {'measure': 'The confidence was assessed using the Confidence after Stroke Measure (CaSM)', 'timeFrame': 'immediately after and 3 months after the intervention', 'description': 'total scores ranging from 0 to 81 and higher scores representing higher confidence.'}, {'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'immediately after and 3 months after the intervention', 'description': 'total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke Patients With Depression']}, 'referencesModule': {'references': [{'pmid': '37938871', 'type': 'DERIVED', 'citation': 'Liu YE, Lv J, Sun FZ, Liang JJ, Zhang YY, Chen J, Jiang WJ. Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. Brain Behav. 2023 Dec;13(12):e3260. doi: 10.1002/brb3.3260. Epub 2023 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question\\[s\\] it aims to answer are:\n\n* Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke,\n* the interventional efficacy could be maintained at 3-month follow-up\n* similar benefits would be observed for quality of life (QOL), sleep quality, psychological flexibility, cognitive fusion, and confidence.\n\nThe patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G-ACT and usual care support. the G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. primary diagnosis of acute stroke, the last onset occurred within 2 weeks\n2. being over 18 years old\n3. scoring at least 8 on the HAMD scale\n4. Be conscious and able to communicate effectively with researchers\n5. Primary school education level or above, 6) having signed informed consent.\n\nExclusion Criteria:\n\n1. having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants\n2. a diagnosis of cognitive impairment\n3. receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms\n4. a history of drug abuse or dependence'}, 'identificationModule': {'nctId': 'NCT05727358', 'briefTitle': 'Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression', 'organization': {'class': 'OTHER', 'fullName': 'PLA Rocket Force Characteristic Medical Center'}, 'officialTitle': 'Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression', 'orgStudyIdInfo': {'id': 'Z181100001718041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'G-ACT', 'interventionNames': ['Behavioral: Group-based Acceptance and Commitment Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'Group-based Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'description': 'G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000088', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The PLA Rocket Force Characteristic Medical Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PLA Rocket Force Characteristic Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head nurse', 'investigatorFullName': 'Liu Yun-e', 'investigatorAffiliation': 'PLA Rocket Force Characteristic Medical Center'}}}}