Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 9:58 AM
Study NCT ID:
NCT05490069
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000075782', 'term': 'Cell Phone Use'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])', 'timeFrame': '24-week', 'description': 'A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom'}], 'secondaryOutcomes': [{'measure': 'Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])', 'timeFrame': '24-week', 'description': 'A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms'}, {'measure': 'Stress level (Perceived Stress Scale [PSS-4])', 'timeFrame': '24-week', 'description': 'A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress'}, {'measure': 'Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])', 'timeFrame': '24-week', 'description': 'An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being'}, {'measure': 'Loneliness (UCLA Loneliness Scale [ULS-8])', 'timeFrame': '24-week', 'description': 'An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level of loneliness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Depressive Symptoms', 'Mobile Phone Use']}, 'descriptionModule': {'briefSummary': "The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stroke (ICD-10 codes: I60-I69)\n* Aged ≥18\n* Able to read and communicate in Chinese (Cantonese or Putonghua)\n* Able to use text messaging function on mobile phones\n* MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)\n* Discharged home from hospital within preceding 6 months\n* PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)\n\nExclusion Criteria:\n\n* Currently receiving active stroke care in acute or post-acute inpatient settings\n* Has diagnosis of psychiatric disease or is currently taking psychotropic drug\n* PHQ-9 ≥ 20 (i.e., severe depressive symptom)\n* Currently participating in any type of psychological intervention (e.g., CBT)'}, 'identificationModule': {'nctId': 'NCT05490069', 'briefTitle': 'The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors', 'orgStudyIdInfo': {'id': '20-526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.", 'interventionNames': ['Other: iCBT-based EMI']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Receive general mental health information through instant message.'}], 'interventions': [{'name': 'iCBT-based EMI', 'type': 'OTHER', 'description': "Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and real-time chat-based support messages, delivered according to participants' preferences.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong PHAB Association', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong Stroke Association', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'NT West Community Rehabilitation Day Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Society for Rehabilitation', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Tung Wah Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'United Christian Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}