Feasibility Study for Online Mindfulness for GAD

NCT05059834 | Completed

• 1 other identifier: 2020.385
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety Generalized

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 7-item Generalized Anxiety Disorder questionnaire

  baseline and 2-month

• 9-item Patient Health Questionnaire

  baseline and 2-month

• Penn State Worry Questionnaire

  baseline and 2-month

• Five Facet Mindfulness Questionnaire

  baseline and 2-month

Study Arms (2)

online mindfulness resources + usual care

EXPERIMENTAL

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

usual care

OTHER

patients will receive usual care from doctors

Behavioral: usual care

Interventions

online mindfulness resources BEHAVIORAL

a free mindfulness resource online for patients with general anxiety disorder

online mindfulness resources + usual care

usual care BEHAVIORAL

patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

School of public health and primary care

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 28, 2021
• Study Start: October 15, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)