StressNCT04346082
Feasibility of Online Based Mindfulness Interventions During COVID-19 Outbreak
A study testing online mindfulness group in people with Stress, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- online mindfulness group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2020to 30 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of old,
- able to speak and communicate in Cantonese
- can read Chinese or English (because they will be asked to fill in an online questionnaire).
Who cannot join
- actively suicidal,
- currently abusing restricted psychoactive substances
- diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Online Based Mindfulness Interventions to Relieve Distress During COVID-19 Outbreak in a Chinese Population: a Proof-of-concept Trial
The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence
This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.
- Conditions
- Stress
- Being tested
- online mindfulness group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness groupBehavioural
Each weekly mindfulness session will last 45 to 60 minutes and will be held on an online platform (e.g. Zoom) via a livestream video. It will consist of short mindfulness exercise(s) of 10-30 minutes, including mindful tasting, mindful stretching, mindful walking, and body scan followed by group discussion to share, explore and make sense of the meditative experience. The intervention will be held in Cantonese.
| Study group | Role | What they receive |
|---|---|---|
| online mindfulness group | Experimental | Not described Receives: Behavioral: online mindfulness group |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recruitment
the rate of recruitment to recruit participants
Measured: from recruitment to end of study, up to 1 year
rate of attendence
the number of attendance to the mindfulness online group
Measured: from recruitment to end of study, up to 1 year
Secondary outcomes (2)
Depression, Anxiety and Stress Scale (DASS-21)
Depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS-21), which was validated in Chinese population with high internal consistency. The 21-item DASS-21 has three subscales designed to measure depression, anxiety and stress, with each subscale containing 7 items. Participants are required to rate each statement in DASS-21 using a 4-point Likert scale from "did not apply to me at all" to "applied to me very much or most of the time" in the prior one week. Higher scores represent higher level of psychological distress.
Measured: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Sense of Coherence Scale
Sense of Coherence (SOC) will be assessed by the 13-item Sense of Coherence Scale (SOC-13) based on Antonovsky (1987)'s measurement of the comprehensibility, manageability, and meaningfulness of a person's life events . Participants will rate each statement in SOC-13 on a 7-point Likert scale from "very often" to "very seldom or never". SOC-13 has been validated in Chinese population with high internal consistency. The higher the score, the higher the sense of coherence
Measured: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Aug 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Why it stopped: Regular mindfulness online sessions were not carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- participants receiving online mindfulness session(s)
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04346082
- Sponsor's protocol ID
- online-mind
- Status last verified
- Jul 2021
- First submitted
- 7 Apr 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may share data on request of investigators
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Online Based Mindfulness Interventions to Relieve Distress During COVID-19 Outbreak in a Chinese Population: a Proof-of-concept Trial
- ClinicalTrials.gov ID
- NCT04346082
- Acronym / sponsor ID
- online-mind
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regular mindfulness online sessions were not carried out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 15 Apr 2020 (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.
The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence
This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- participants receiving online mindfulness session(s)
| Arm | Type | Receives |
|---|---|---|
| online mindfulness group | Experimental | Behavioral: online mindfulness group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of old,
- able to speak and communicate in Cantonese
- can read Chinese or English (because they will be asked to fill in an online questionnaire).
Key exclusion criteria (3 listed)
- actively suicidal,
- currently abusing restricted psychoactive substances
- diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).
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 groupEach weekly mindfulness session will last 45 to 60 minutes and will be held on an online platform (e.g. Zoom) via a livestream video. It will consist of short mindfulness exercise(s) of 10-30 minutes, including mindful tasting, mindful stretching, mindful walking, and body scan followed by group discussion to share, explore and make sense of the meditative experience. The intervention will be held in Cantonese. | Behavioural | online mindfulness group |
Primary outcome
rate of recruitment
Time frame: from recruitment to end of study, up to 1 year
the rate of recruitment to recruit participants
rate of attendence
Time frame: from recruitment to end of study, up to 1 year
the number of attendance to the mindfulness online group
2 secondary outcomes
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Sense of Coherence Scale
Time frame: on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided. may share data on request of investigators
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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 group in people with Stress, 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 Jul 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
rate of recruitment (time frame: from recruitment to end of study, up to 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 27 Jul 2021.