Anxiety GeneralizedNCT05059834
Feasibility Study for Online Mindfulness for GAD
A study testing online mindfulness resources in people with Anxiety Generalized, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Generalized
- What is being tested?
- online mindfulness resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
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
- Being tested
- online mindfulness resources, usual care
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness resourcesBehavioural
a free mindfulness resource online for patients with general anxiety disorder
usual careBehavioural
patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: online mindfulness resources |
| usual care | Other | patients will receive usual care from doctors Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rate
rate of recruitment during the trial period
Measured: through study completion, an average of 1 year
dropout rate
rate of dropout during the trial period
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
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
Measured: baseline and 2-month
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
Measured: baseline and 2-month
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
Measured: baseline and 2-month
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
Measured: baseline and 2-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety GeneralizedStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059834
- Sponsor's protocol ID
- 2020.385
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will share on a reasonable request from other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05059834
- Acronym / sponsor ID
- 2020.385
- Conditions
- Anxiety Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online mindfulness resources + usual care | Experimental | Behavioral: online mindfulness resourcesThe 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. |
| usual care | Other | Behavioral: usual carepatients will receive usual care from doctors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online mindfulness resourcesa free mindfulness resource online for patients with general anxiety disorder | Behavioural | online mindfulness resources + usual care |
| usual carepatient will continue to receive drug and advice from doctors and nurses for their anxiety disorder | Behavioural | usual care |
Primary outcome
recruitment rate
Time frame: through study completion, an average of 1 year
rate of recruitment during the trial period
dropout rate
Time frame: through study completion, an average of 1 year
rate of dropout during the trial period
4 secondary outcomes
7-item Generalized Anxiety Disorder questionnaire
Time frame: baseline and 2-month
9-item Patient Health Questionnaire
Time frame: baseline and 2-month
Penn State Worry Questionnaire
Time frame: baseline and 2-month
Five Facet Mindfulness Questionnaire
Time frame: baseline and 2-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided. will share on a reasonable request from other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online mindfulness resources in people with Anxiety Generalized, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rate (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.