Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 8:10 PM
Study NCT ID:
NCT07064551
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking was no possible in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-Criticism and Self-Reassurance', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Short Form of Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS-SF); higher scores indicate a greater sense of inadequacy (score 0-20) (worse outcome), self-hate (score 0-16) (worse outcome), and self-reassurance (score 0-20) (better outcome)'}, {'measure': 'Rumination', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Ruminative Response Scale - Brooding Subscale (RRS-Brooding); range 0-15; higher scores indicate higher frequency of depressive rumination (worse outcome)'}, {'measure': 'Resilience', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Connor-Davidson Resilience Scale 2-Item (CD-RISC-2); range 0-8; higher scores indicate higher levels of resilience or better equipped to bounce back after stressful events (better outcome)'}, {'measure': 'General Self-Efficacy', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Single-item General Self-Efficacy Scale (SI-DSES); range 1-5; higher scores indicate higher levels of self-efficacy (better outcome)'}, {'measure': 'Stressful Events', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Self-reported stressful events, e.g. illness, death of close relative/friends.'}, {'measure': 'Perceived Neighbourhood Environment', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Self-perceived convenience to access leisure, shopping, and community facilities and social and medical services'}], 'primaryOutcomes': [{'measure': 'Changes in Depressive Symptoms', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores indicate higher levels of depressive symptoms (worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Changes in Anxiety Symptoms', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Generalized Anxiety Disorder 2-item scale (GAD-2); range 0-6; higher scores indicate higher levels of anxiety symptoms (worse outcome)'}, {'measure': 'Changes in Loneliness', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'UCLA Loneliness Scale (UCLA-3); range 0-9; higher scores indicate higher levels of perceived loneliness (worse outcome)'}, {'measure': 'Changes in Health Service Use', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'Self-reported use of mental health services and medication in the past three months.\n\nService data from Hospital Authority, covering information on outpatient visits, hospitalisation days, Accident and Emergency service utilisation, types of medications and operations, and any other major cost items that may be affected by depression with cost implications.'}, {'measure': 'Changes in Health-Related Quality of Life', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months', 'description': 'EQ-5D-5L; range 0-1; higher scores indicate higher levels of health-related quality of life (better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depressive symptoms', 'Mental health', 'Medical-social collaboration', 'Integrated health and social care', 'Stepped-care intervention'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a medical-social collaboration model works to reduce depressive symptoms in middle-aged and older adults with subsyndromal depressive symptoms who are waiting for their first psychiatric appointment. Secondary outcomes of the study include reduced anxiety symptoms, reduced loneliness, reduced rumination, reduced self-criticism, improved self-reassurance, improved resilience, improved self-efficacy, improved health-related quality of life, as well as improved quality-adjusted life years, and reduced healthcare service utilisation.\n\nResearchers will compare a medical-social collaboration model to a self-management booklet.\n\nParticipants will:\n\n* Receive CBT-based stepped-care interventions through the medical-social collaboration model or a self-management booklet.\n* Complete a survey about their mental health and service use every three months until their first psychiatric appointment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently awaiting psychiatric services provided by the Hospital Authority\n* Have depressive symptoms of at least mild severity\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* A known history of autism spectrum disorder, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia\n* Imminent suicidal risk (temporary exclusion)\n* Communication difficulties that preclude participation"}, 'identificationModule': {'nctId': 'NCT07064551', 'briefTitle': 'Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms', 'orgStudyIdInfo': {'id': 'UW 24-649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JC JoyAge stepped-care model', 'interventionNames': ['Behavioral: Cognitive behavioural therapy-based stepped-care intervention', 'Other: Self-management booklet']}, {'type': 'OTHER', 'label': 'Usual care with minimal support', 'interventionNames': ['Other: Self-management booklet']}], 'interventions': [{'name': 'Cognitive behavioural therapy-based stepped-care intervention', 'type': 'BEHAVIORAL', 'description': 'After initial clinical assessment, participants will be offered interventions based on their depressive symptom severity (Patient Health Questionnaire-9-item \\[PHQ-9\\]). Mild symptoms (PHQ-9=5-9): 6 weekly low intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderate symptoms (PHQ-9=10-14): 6 weekly high intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderately severe symptoms (PHQ-9≥15): high intensity individual or group CBT-based intervention. Trained peer supporters will be matched to participants to walk them through the process with regular follow-up.', 'armGroupLabels': ['JC JoyAge stepped-care model']}, {'name': 'Self-management booklet', 'type': 'OTHER', 'description': 'The booklet incorporates components of behavioural activation, which encourages participants to engage in meaningful activities in daily life to change their mood. Trained research assistants will regularly check in with the participants to monitor their depressive symptoms.', 'armGroupLabels': ['JC JoyAge stepped-care model', 'Usual care with minimal support']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Yao Du, PhD', 'role': 'CONTACT', 'email': 'yaodu@hku.hk', 'phone': '852-39175594'}, {'name': 'Walker SH Au', 'role': 'CONTACT', 'email': 'ashwalk@hku.hk'}, {'name': 'Terry YS Lum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Yao Du, PhD', 'role': 'CONTACT', 'email': 'yaodu@hku.hk', 'phone': '852-39175594'}, {'name': 'Walker SH Au', 'role': 'CONTACT', 'email': 'ashwalk@hku.hk'}], 'overallOfficials': [{'name': 'Terry YS Lum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}, {'name': 'Gloria HY Wong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}, {'name': 'Wai Chi Chan, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to participant confidentiality reasons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Authority Hong Kong West Cluster', 'class': 'UNKNOWN'}, {'name': 'Hospital Authority Hong Kong East Cluster', 'class': 'UNKNOWN'}, {'name': 'Hospital Authority Kolwoon Central Cluster', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Terry Y.S. Lum', 'investigatorAffiliation': 'The University of Hong Kong'}}}}