Feasibility Study for Online Mindfulness for GAD

Study Overview
=================
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

Official Title
-----------------
Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder

Conditions
-----------------
Anxiety Generalized

Intervention / Treatment
-----------------
* Behavioral: online mindfulness resources
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online mindfulness resources + usual care<br>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. | Behavioral: online mindfulness resources<br>* a free mindfulness resource online for patients with general anxiety disorder<br>|
| Other: usual care<br>patients will receive usual care from doctors | Behavioral: usual care<br>* patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate | rate of recruitment during the trial period | through study completion, an average of 1 year | 
| dropout rate | rate of dropout during the trial period | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |