Feasibility Study for Online Mindfulness for GAD

Anxiety Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059834
• Other study ID #: 2020.385
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Generalized

Intervention

Behavioral:
• online mindfulness resources
a free mindfulness resource online for patients with general anxiety disorder
• usual care
patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder

Locations

Country	Name	City	State
Hong Kong	School of public health and primary care	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recruitment rate	rate of recruitment during the trial period	through study completion, an average of 1 year
Primary	dropout rate	rate of dropout during the trial period	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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