Anxiety Generalized
Conditions
Brief summary
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
Interventions
BEHAVIORALonline mindfulness resources
a free mindfulness resource online for patients with general anxiety disorder
BEHAVIORALusual care
patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recruitment rate | through study completion, an average of 1 year | rate of recruitment during the trial period |
| dropout rate | through study completion, an average of 1 year | rate of dropout during the trial period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-item Generalized Anxiety Disorder questionnaire | baseline and 2-month | a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-21. the higher the score, the more severe the anxiety symptoms |
| 9-item Patient Health Questionnaire | baseline and 2-month | a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-27. the higher the score, the more severe the depressive symptoms |
| Penn State Worry Questionnaire | baseline and 2-month | a validated questionnaire to measure worry. The possible score ranged from 16-80. the higher the score, the more severe the worries |
| Five Facet Mindfulness Questionnaire | baseline and 2-month | a validated questionnaire to measure mindfulness. The possible score ranged from 1-5. the higher the score, the more mindful the participants are |
Countries
Hong Kong
Outcome results
None listed