Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059834
Other study ID # 2020.385
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Completed NCT04626804 - Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community N/A
Completed NCT03712410 - A Problem Solving Intervention for Hospice Caregivers N/A
Completed NCT04562948 - Community Applications of the MindShift App
Not yet recruiting NCT06076746 - Evaluation of Psychotherapeutic Intervention Model in Nursing N/A
Completed NCT04338750 - Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia N/A
Completed NCT04453449 - The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks
Completed NCT04950088 - Reduction of Perioperative Anxiety Using a Hand-held Video Game Device N/A
Terminated NCT04784182 - Anti-anxiety Biotics for Breast Cancer Survivors N/A
Not yet recruiting NCT06100406 - Sound Healing for Anxiety: A Randomized Controlled Trial N/A
Recruiting NCT05549102 - CBT and the Neural Circuits of Anxiety
Completed NCT05027880 - Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety N/A
Completed NCT05407064 - A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms Phase 2
Recruiting NCT06237439 - Sharing HaRT in New Expanses N/A
Withdrawn NCT02072252 - Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men Phase 1/Phase 2
Recruiting NCT05447689 - Mind-Body Skills Group for Graduate Students N/A
Completed NCT03491384 - Anxiety, Inflammation, and Stress