Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-13 @ 1:01 PM
Study NCT ID:
NCT06949657
Status:
TERMINATED
Last Update Posted:
2025-06-24
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'the sponsor has determined that access to the full dataset is no longer available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Function', 'timeFrame': 'Baseline to 6 weeks post-intervention', 'description': 'Improvement in global cognitive function assessed via the Montreal Cognitive Assessment (MoCA), focusing on memory, attention, and executive function. Higher scores indicate better cognition (range: 0-30).'}], 'secondaryOutcomes': [{'measure': 'Psychological Flexibility (AAQ-II)', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Scores on the Acceptance and Action Questionnaire-II (7 items, Likert scale 1-7). Lower scores indicate greater flexibility.'}, {'measure': 'Self-Efficacy (GSES)', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'General Self-Efficacy Scale (10 items, scores 10-40). Higher scores reflect stronger self-efficacy.'}, {'measure': 'Family Functioning (FACES II-CV)', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Family Adaptability and Cohesion Evaluation Scale (cohesion + adaptability subscales). Higher scores indicate healthier family dynamics.'}, {'measure': 'Stigma Reduction (SSMI-C)', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Stigma Scale for Mental Illness (28 items). Lower scores on Discrimination/Illness Concealment subscales indicate reduced stigma.'}, {'measure': 'Quality of Life (SQLS)', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Schizophrenia Quality of Life Scale (30 items). Lower scores indicate better QoL in psychosocial, motivation, and symptom domains.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia Disorders', 'Cognitive Impairment', 'Acceptance and Commitment Therapy']}, 'descriptionModule': {'briefSummary': 'ACT combined with stratified intervention improved cognitive function and quality of life in elderly schizophrenia patients by enhancing psychological flexibility and family support.', 'detailedDescription': 'This study analyzes factors influencing cognitive impairment and evaluates the efficacy of a stratified intervention combining Acceptance and Commitment Therapy (ACT) with these factors to improve cognitive function and quality of life. A total of 149 elderly patients with schizophrenia were enrolled, split into cognitive impairment (n = 86) and non-cognitive impairment (n = 63) groups. A combined case-control and randomized controlled trial design was employed. Logistic regression was used to identify independent risk factors. Cognitive impairment patients were randomly assigned to either the conventional treatment group (n = 39) or the ACT group (n = 39) for a 6-week intervention. Evaluation instruments included the AAQ-II (psychological flexibility), GSES (self-efficacy), FACES II-CV (family functioning), SSMI-C (internalized stigma), and SQLS (quality of life).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1)Meets the diagnostic criteria for schizophrenia as defined in the International Classification of Diseases, Tenth Revision (ICD-10);\n* (2) age \\> 60 years;\n* (3)possesses at least a primary school education, enabling independent completion of all questionnaires;\n* (4) has been taking antipsychotic medication continuously and regularly for at least one year during the enrollment period, with current symptoms and disease status stabilized in the maintenance phase;\n* (5)informed consent obtained from the patient or their family/guardian.\n\nExclusion Criteria:\n\n* (1) Coexisting organic mental disorders, affective disorders, or similar conditions;\n* (2) coexisting physical illnesses that may affect cognitive function, such as hepatic or renal dysfunction;\n* (3) alcohol dependence or dependence on psychoactive substances;\n* (4) receipt of electroconvulsive therapy within the past three months.'}, 'identificationModule': {'nctId': 'NCT06949657', 'briefTitle': 'Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and', 'organization': {'class': 'OTHER', 'fullName': "Third People's Hospital, Huzhou City, Zhejiang Province, China"}, 'officialTitle': 'Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and the Application Effect of Acceptance and Commitment Therapy Nursing Model', 'orgStudyIdInfo': {'id': 'No. 2025-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'the conventional treatment group', 'description': 'Patients received conventional mental health education once weekly for 6 weeks, covering schizophrenia symptoms, treatment, and prognosis. Standard nursing care and antipsychotic medications (e.g., olanzapine, quetiapine) were maintained without additional psychological interventions.', 'interventionNames': ['Other: the conventional treatment group']}, {'type': 'OTHER', 'label': 'the ACT group', 'description': 'Patients received ACT-based nursing interventions tailored to risk factors (e.g., age ≥70, long disease duration), including:\n\nACT modules: Acceptance, cognitive defusion, mindfulness, values clarification, and committed action.\n\nAdjunct strategies: Family therapy, Tai Chi, and crisis planning. Frequency: Daily practice + 1-2 group sessions/week for 6 weeks. Goal: Enhance psychological flexibility, reduce stigma, and improve cognitive function.', 'interventionNames': ['Other: the ACT group']}], 'interventions': [{'name': 'the conventional treatment group', 'type': 'OTHER', 'description': 'Patients received conventional mental health education once weekly for 6 weeks, covering schizophrenia symptoms, treatment, and prognosis. Standard nursing care and antipsychotic medications (e.g., olanzapine, quetiapine) were maintained without additional psychological interventions.', 'armGroupLabels': ['the conventional treatment group']}, {'name': 'the ACT group', 'type': 'OTHER', 'description': 'Patients received ACT-based nursing interventions tailored to risk factors (e.g., age ≥70, long disease duration), including:\n\nACT modules: Acceptance, cognitive defusion, mindfulness, values clarification, and committed action.\n\nAdjunct strategies: Family therapy, Tai Chi, and crisis planning. Frequency: Daily practice + 1-2 group sessions/week for 6 weeks. Goal: Enhance psychological flexibility, reduce stigma, and improve cognitive function.', 'armGroupLabels': ['the ACT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313000', 'city': 'Huzhou', 'country': 'China', 'facility': "Huzhou Third People's Hospital", 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}], 'overallOfficials': [{'name': 'Ying Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Huzhou Third People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Third People's Hospital, Huzhou City, Zhejiang Province, China", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ying Xu', 'investigatorAffiliation': "Third People's Hospital, Huzhou City, Zhejiang Province, China"}}}}