Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 5:27 PM
Study NCT ID:
NCT06132061
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of depression', 'timeFrame': 'Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.', 'description': 'A simplified version of Geriatric Depression Scale(GDS-15) will be used to mesure the level of depression. The scale has 15 items and asks the elderly to answer "yes" or "no" based on how they have felt in the past week. The "yes" is 1 point, "no" is 0 points. The higher the score indicates the more obvious depressive symptoms. The total score is 15 points. 0-4 points indicate no depression, 5-9 points indicate mild depression, and 10-15 points indicate moderate to severe depression.'}], 'secondaryOutcomes': [{'measure': 'Psychological flexibility', 'timeFrame': 'Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.', 'description': "Psychological flexibility refers to an individual's ability to be open and flexible to his or her own experiences, thoughts or feelings, which can prompt him or her to take action or make changes when engaged in difficult events. Psychological flexibility can be measured by the simplified Multidimensional Psychological Flexibility Inventory(MPFI-24). The scale consists of 24 items and is divided into two subscales: psychological flexibility (PF) and psychological inflexibility (PI). Each items is rated by the subject on a 6-point Likert scale (1＝never to 6＝always). Higher subscale scores were associated with higher levels of psychological flexibility or psychological inflexibility."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression in Old Age']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to compare the effect of three level interventions(universal prevention, selective prevention and targeted prevention) in elderly depression and find out the most efficient intervention path. The main questions it aims to answer are:\n\n* Whether the pre-disease three-level prevention model (universal prevention, selective prevention and targeted prevention) is applicable for elderly depression in urban communities;\n* Which level of intervention has the best effect on elderly depression.\n\nParticipants will be given the following treatments:\n\n* Level 1 intervention(universal prevention): Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.\n* Level 2 intervention(selective prevention): Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms.\n* Level 3 intervention(targeted prevention): Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.\n\nResearchers will compare control group to see if the three levels of intervention have a significant effect."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 60 and above;\n2. Permanent residents of urban communities in China;\n3. Geriatric Depression Scale (GDS-15) \\< 9 points;\n4. There are susceptibility factors such as living alone, poverty, and suffering from serious diseases.\n\nExclusion Criteria:\n\n1. There is suicidal behavior or risk;\n2. A history of any other mental illness, including drug or alcohol dependence;\n3. Those who have speech and hearing disorder and cannot communicate normally;\n4. Geriatric Depression Scale (GDS-15) ≥10 points;\n5. Do not agree to participate in the research.'}, 'identificationModule': {'nctId': 'NCT06132061', 'briefTitle': 'Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Yunnan University'}, 'officialTitle': 'Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community', 'orgStudyIdInfo': {'id': '2023221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group for universal prevention', 'description': 'Level 1 intervention (universal prevention) group', 'interventionNames': ['Other: universal prevention']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group for selective prevention', 'description': 'Level 2 intervention(selective prevention) group', 'interventionNames': ['Other: selective prevention']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group for targeted prevention', 'description': 'Level 3 intervention(targeted prevention) group', 'interventionNames': ['Other: targeted prevention']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: Waiting treatment.']}], 'interventions': [{'name': 'universal prevention', 'type': 'OTHER', 'description': "Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.", 'armGroupLabels': ['Intervention group for universal prevention']}, {'name': 'selective prevention', 'type': 'OTHER', 'description': 'Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms.', 'armGroupLabels': ['Intervention group for selective prevention']}, {'name': 'targeted prevention', 'type': 'OTHER', 'description': "Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.", 'armGroupLabels': ['Intervention group for targeted prevention']}, {'name': 'Waiting treatment.', 'type': 'OTHER', 'description': 'Waiting treatment.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Huashan Street', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Yunnan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Department of Social Work', 'investigatorFullName': 'Tan Tang', 'investigatorAffiliation': 'Affiliated Hospital of Yunnan University'}}}}