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Feasibility Study for Online Mindfulness for GAD

Primary Purpose

Anxiety Generalized

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
online mindfulness resources
usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Generalized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of public health and primary care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

online mindfulness resources + usual care

usual care

Arm Description

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.

patients will receive usual care from doctors

Outcomes

Primary Outcome Measures

recruitment rate
rate of recruitment during the trial period
dropout rate
rate of dropout during the trial period

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
September 13, 2021
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05059834
Brief Title
Feasibility Study for Online Mindfulness for GAD
Official Title
Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
online mindfulness resources + usual care
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
Other
Arm Description
patients will receive usual care from doctors
Intervention Type
Behavioral
Intervention Name(s)
online mindfulness resources
Intervention Description
a free mindfulness resource online for patients with general anxiety disorder
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder
Primary Outcome Measure Information:
Title
recruitment rate
Description
rate of recruitment during the trial period
Time Frame
through study completion, an average of 1 year
Title
dropout rate
Description
rate of dropout during the trial period
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
7-item Generalized Anxiety Disorder questionnaire
Description
a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-21. the higher the score, the more severe the anxiety symptoms
Time Frame
baseline and 2-month
Title
9-item Patient Health Questionnaire
Description
a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-27. the higher the score, the more severe the depressive symptoms
Time Frame
baseline and 2-month
Title
Penn State Worry Questionnaire
Description
a validated questionnaire to measure worry. The possible score ranged from 16-80. the higher the score, the more severe the worries
Time Frame
baseline and 2-month
Title
Five Facet Mindfulness Questionnaire
Description
a validated questionnaire to measure mindfulness. The possible score ranged from 1-5. the higher the score, the more mindful the participants are
Time Frame
baseline and 2-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
School of public health and primary care
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
will share on a reasonable request from other researchers

Learn more about this trial

Feasibility Study for Online Mindfulness for GAD

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