Feasibility Study for Online Mindfulness for GAD

NCT ID: NCT05059834

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Anxiety Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

online mindfulness resources

Intervention Type BEHAVIORAL

a free mindfulness resource online for patients with general anxiety disorder

usual care

patients will receive usual care from doctors

Group Type OTHER

usual care

Intervention Type BEHAVIORAL

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

Interventions

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online mindfulness resources

a free mindfulness resource online for patients with general anxiety disorder

Intervention Type BEHAVIORAL

usual care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lee Kam Pui

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of public health and primary care

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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2020.385

Identifier Type: -

Identifier Source: org_study_id

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