Anxiety Generalized Clinical Trial
Official title:
Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
Verified date | August 2023 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 36 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - received a diagnosis of GAD in the computerized record system (CMS) in Hong Kong hospital authority - score =10 on the 7-item Generalized Anxiety Disorder scale (GAD-7), signifying active moderate anxiety symptoms - used any website in prior 12 months - received stable dose of psychoactive medications in last 2 months Exclusion Criteria: - any diagnosed psychotic disorder - diagnosis of dementia - any diagnosed substance abuse disorder (except smoking) - active suicidal ideation (score =1 on 9-item Patient Health Questionnaire - had regular mindfulness meditation practice in last 6 months or had participated in MBSR/MBCT course |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of public health and primary care | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recruitment rate | rate of recruitment during the trial period | through study completion, an average of 1 year | |
Primary | dropout rate | rate of dropout during the trial period | through study completion, an average of 1 year | |
Secondary | 7-item Generalized Anxiety Disorder questionnaire | a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-21. the higher the score, the more severe the anxiety symptoms | baseline and 2-month | |
Secondary | 9-item Patient Health Questionnaire | a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-27. the higher the score, the more severe the depressive symptoms | baseline and 2-month | |
Secondary | Penn State Worry Questionnaire | a validated questionnaire to measure worry. The possible score ranged from 16-80. the higher the score, the more severe the worries | baseline and 2-month | |
Secondary | Five Facet Mindfulness Questionnaire | a validated questionnaire to measure mindfulness. The possible score ranged from 1-5. the higher the score, the more mindful the participants are | baseline and 2-month |
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