Feasibility Study for Online Mindfulness for GAD

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety Generalized
• Intervention / Treatment: Behavioral: online mindfulness resources; Behavioral: usual care

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of public health and primary care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2020.385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: will share on a reasonable request from other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No