Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-30 @ 7:04 AM
Study NCT ID:
NCT05059834
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study for Online Mindfulness for GAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recruitment rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'rate of recruitment during the trial period'}, {'measure': 'dropout rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'rate of dropout during the trial period'}], 'secondaryOutcomes': [{'measure': '7-item Generalized Anxiety Disorder questionnaire', 'timeFrame': 'baseline and 2-month', 'description': 'a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-21. the higher the score, the more severe the anxiety symptoms'}, {'measure': '9-item Patient Health Questionnaire', 'timeFrame': 'baseline and 2-month', 'description': 'a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-27. the higher the score, the more severe the depressive symptoms'}, {'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'baseline and 2-month', 'description': 'a validated questionnaire to measure worry. The possible score ranged from 16-80. the higher the score, the more severe the worries'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'baseline and 2-month', 'description': 'a validated questionnaire to measure mindfulness. The possible score ranged from 1-5. the higher the score, the more mindful the participants are'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety Generalized']}, 'descriptionModule': {'briefSummary': 'Method: . Forty patients with general anxiety disorder will be randomized in 1:1 ratio to the online resource plus usual care, and to usual care control group by stratified block randomization. Measurements including 7-item Generalized Anxiety Disorder questionnaire, 9-item Patient Health Questionnaire, Penn State Worry questionnaire, and Five Facet Mindfulness Questionnaire will be made at baseline and at 2-month. Rate of recruitment, drop out and website usage will be collected. All patients in the intervention arm will be interviewed to assess the clarity of the app and user experience. The scores between the two arms will be compared by t-test and the transcripts of the patient interviews will be analysed using thematic analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* received a diagnosis of GAD in the computerized record system (CMS) in Hong Kong hospital authority\n* score ≥10 on the 7-item Generalized Anxiety Disorder scale (GAD-7), signifying active moderate anxiety symptoms\n* used any website in prior 12 months\n* received stable dose of psychoactive medications in last 2 months\n\nExclusion Criteria:\n\n* any diagnosed psychotic disorder\n* diagnosis of dementia\n* any diagnosed substance abuse disorder (except smoking)\n* active suicidal ideation (score ≥1 on 9-item Patient Health Questionnaire\n* had regular mindfulness meditation practice in last 6 months or had participated in MBSR/MBCT course'}, 'identificationModule': {'nctId': 'NCT05059834', 'briefTitle': 'Feasibility Study for Online Mindfulness for GAD', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': '2020.385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'online mindfulness resources + usual care', 'description': 'The mindfulness online resources consisted of 4 weekly modules. Mindfulness exercises, including body scan, mindful breathing, mindful eating, mindful walking, 3-min breathing space, and thought distancing exercise, are audio-recorded to facilitate participants to practice mindfulness. Readings and graphics are included to explain the concept of mindfulness and to share with participants the common difficulties that participants may come across during mindfulness practices.', 'interventionNames': ['Behavioral: online mindfulness resources']}, {'type': 'OTHER', 'label': 'usual care', 'description': 'patients will receive usual care from doctors', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'online mindfulness resources', 'type': 'BEHAVIORAL', 'description': 'a free mindfulness resource online for patients with general anxiety disorder', 'armGroupLabels': ['online mindfulness resources + usual care']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'School of public health and primary care', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will share on a reasonable request from other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Lee Kam Pui', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}