Feasibility Study for Online Mindfulness for GAD

Not Applicable

Completed

• Conditions: Anxiety Generalized
• Interventions: Behavioral: online mindfulness resources; Behavioral: usual care

• Registration Number: NCT05059834
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-28
• Study Start: 2021-10-15
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
online mindfulness resources + usual care	online mindfulness resources	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.
usual care	usual care	patients will receive usual care from doctors

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

School of public health and primary care; 🇭🇰 Hong Kong, Hong Kong