Feasibility Study for Online Mindfulness for GAD

The Chinese University of Hong Kong

Status: Completed

Conditions: Anxiety Generalized

Treatments: Behavioral: usual care; Behavioral: online mindfulness resources

Study type: Interventional

Funder types: Other

Identifiers

NCT05059834

2020.385

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

online mindfulness resources + usual care

Experimental group

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.

Treatment:

Behavioral: online mindfulness resources

usual care

Other group

Description:

patients will receive usual care from doctors

Treatment:

Behavioral: usual care