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OpenTrials
Completed

NCT Number: NCT05059834

Feasibility Study for Online Mindfulness for GAD

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

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Key information

Conditions

Anxiety Generalized Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of public health and primary care

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

online mindfulness resources

Behavioral

a free mindfulness resource online for patients with general anxiety disorder

Usual Care

Behavioral

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

Primary outcomes

  1. recruitment rate

    Time frame: through study completion, an average of 1 year

    rate of recruitment during the trial period

  2. dropout rate

    Time frame: through study completion, an average of 1 year

    rate of dropout during the trial period

Secondary outcomes

  1. 7-item Generalized Anxiety Disorder questionnaire

    Time frame: baseline and 2-month

    a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-21. the higher the score, the more severe the anxiety symptoms

  2. 9-item Patient Health Questionnaire

    Time frame: baseline and 2-month

    a validated questionnaire to measure anxiety symptoms. Possible score ranged from 0-27. the higher the score, the more severe the depressive symptoms

  3. Penn State Worry Questionnaire

    Time frame: baseline and 2-month

    a validated questionnaire to measure worry. The possible score ranged from 16-80. the higher the score, the more severe the worries

  4. Five Facet Mindfulness Questionnaire

    Time frame: baseline and 2-month

    a validated questionnaire to measure mindfulness. The possible score ranged from 1-5. the higher the score, the more mindful the participants are

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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