Mental Health IssueNCT05056428
Effects of Mindfulness Training on Emotional Care Strategies
A study testing 8-week mindfulness program in people with Mental Health Issue, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- 8-week mindfulness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Sep 2021to 31 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years old or above
- Working in local schools or education institutions
- Willing to participate in mindfulness training voluntarily
Who cannot join
- Have history of neurological or psychiatric disorder, brain injury, birth complications, or significant sensory impairment
- Currently under medications that are known to affect the brain (e.g. anti-depressants, epileptica, tranquilizer, sleep medication, psychotropics, ritalin, concerta, etc.)
- Experiencing severe or unstable mental health condition currently
- Completed 8-week mindfulness training previously
- Unwilling to go by random assignment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Jockey Club "Peace and Awareness" Mindfulness Culture in Schools Initiative, Faculty of Social Sciences, The University of Hong Kong
Hong Kong
About this study
Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to investigate 1) the effects of mindfulness training on teachers' well-being (i.e. general health, positive affect, stress, negative affect); 2) whether decentering strategy (vs. cognitive reappraisal strategy) is nurtured by mindfulness practice; and 3) whether decentering instead of cognitive reappraisal is the mediator that explains the impact of mindfulness on well-being. Participants will be randomized to either intervention (8-week .b Foundations course) or waiting-list control condition.
Read the detailed description
All the participants will complete an online survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention. A subset of participants (N = 30) will complete an electroencephalography (EEG) experiment.
Prior to the experiment, participants will complete an online questionnaire writing down eight recent autobiographical situations: four reflecting a neutral experience, two reflecting events that triggered anxiety, and two reflecting events that triggered sadness. After writing about each situation, participants will be asked to identify five keywords that are both unique and tightly linked to each situation.
During the experiment, participants will be reminded of the autobiographical situations in the computerized task. Participants will be asked to view the keywords (i.e. control condition); step back and view the keywords like an impartial observer, allowing whatever thoughts or emotions arise to come and go (i.e. decentering condition); and think about the keywords from different perspective to minimize negative emotions (i.e. reappraisal condition). EEG will be recorded while participants complete the task. Participants will receive $200 Hong Kong dollars each time as a remuneration for the time to participate in the experiment.
- Conditions
- Mental Health Issue
- Being tested
- 8-week mindfulness program
- Keywords
- mindfulness, teacher mental health, emotional care, decentering, cognitive reappraisal, mindfulness-based intervention for teachers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week mindfulness programBehavioural
The .b Foundations course is an 8-week mindfulness program developed by Mindfulness in Schools Project (MiSP) for school teachers and personnel. It includes a taster session and 8 weekly sessions. Each session lasts for 1.5 hours with a specific theme (e.g. Lesson 1 waking up from autopilot). Formal and informal mindfulness practices (e.g. mindful eating, body scan, mindful walking, habit releaser etc.), psychoeducation, cognitive exercises, inquiry, and home practice are involved.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 8-week mindfulness program Receives: Behavioral: 8-week mindfulness program |
| Wait-list control | No intervention | Participants in wait-list control group will receive the same intervention, two months after experimental group completed the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Health
General Health Questionnaire (GHQ), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Stress
Perceived Stress Scale (PSS), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Secondary outcomes (6)
Change in Positive affect
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Negative affect
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Decentering
Non Reactivity Subscale of Chinese Five Facet Mindfulness Questionnaire (FFMQ-C), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Reappraisal
Reappraisal subscale of Emotion Regulation Questionnaire (ERQ), 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: Baseline, Immediately after intervention, Two-months after intervention
Change in Late positive potential (LPP)
A measure of emotional reactivity in EEG experiment; the amplitude of event-related potential (ERP) time-locked to the presentation of emotional stimulus (-200ms to 6000ms).
Measured: Baseline, Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start25 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Professor Lam Shui-fong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056428
- Sponsor's protocol ID
- UHongKong (JC PandA)
- Status last verified
- May 2022
- First submitted
- 8 Sep 2021
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Training on Emotional Care Strategies
- ClinicalTrials.gov ID
- NCT05056428
- Acronym / sponsor ID
- UHongKong (JC PandA)
- Conditions
- Mental Health Issue
- Keywords
- mindfulness, teacher mental health, emotional care, decentering, cognitive reappraisal, mindfulness-based intervention for teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 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.
Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to investigate 1) the effects of mindfulness training on teachers' well-being (i.e. general health, positive affect, stress, negative affect); 2) whether decentering strategy (vs. cognitive reappraisal strategy) is nurtured by mindfulness practice; and 3) whether decentering instead of cognitive reappraisal is the mediator that explains the impact of mindfulness on well-being. Participants will be randomized to either intervention (8-week .b Foundations course) or waiting-list control condition.
Detailed description
All the participants will complete an online survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention. A subset of participants (N = 30) will complete an electroencephalography (EEG) experiment.
Prior to the experiment, participants will complete an online questionnaire writing down eight recent autobiographical situations: four reflecting a neutral experience, two reflecting events that triggered anxiety, and two reflecting events that triggered sadness. After writing about each situation, participants will be asked to identify five keywords that are both unique and tightly linked to each situation.
During the experiment, participants will be reminded of the autobiographical situations in the computerized task. Participants will be asked to view the keywords (i.e. control condition); step back and view the keywords like an impartial observer, allowing whatever thoughts or emotions arise to come and go (i.e. decentering condition); and think about the keywords from different perspective to minimize negative emotions (i.e. reappraisal condition). EEG will be recorded while participants complete the task. Participants will receive $200 Hong Kong dollars each time as a remuneration for the time to participate in the experiment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: 8-week mindfulness program8-week mindfulness program |
| Wait-list control | No intervention | –Participants in wait-list control group will receive the same intervention, two months after experimental group completed the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years old or above
- Working in local schools or education institutions
- Willing to participate in mindfulness training voluntarily
Key exclusion criteria (5 listed)
- Have history of neurological or psychiatric disorder, brain injury, birth complications, or significant sensory impairment
- Currently under medications that are known to affect the brain (e.g. anti-depressants, epileptica, tranquilizer, sleep medication, psychotropics, ritalin, concerta, etc.)
- Experiencing severe or unstable mental health condition currently
- Completed 8-week mindfulness training previously
- Unwilling to go by random assignment
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 |
|---|---|---|
| 8-week mindfulness programThe .b Foundations course is an 8-week mindfulness program developed by Mindfulness in Schools Project (MiSP) for school teachers and personnel. It includes a taster session and 8 weekly sessions. Each session lasts for 1.5 hours with a specific theme (e.g. Lesson 1 waking up from autopilot). Formal and informal mindfulness practices (e.g. mindful eating, body scan, mindful walking, habit releaser etc.), psychoeducation, cognitive exercises, inquiry, and home practice are involved. | Behavioural | Intervention group |
Primary outcome
Change in General Health
Time frame: Baseline, Immediately after intervention, Two-months after intervention
General Health Questionnaire (GHQ), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change in Stress
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Perceived Stress Scale (PSS), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
6 secondary outcomes
Change in Positive affect
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Change in Negative affect
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Change in Decentering
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Change in Reappraisal
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Change in Mindfulness
Time frame: Baseline, Immediately after intervention, Two-months after intervention
Change in Late positive potential (LPP)
Time frame: Baseline, Immediately after intervention
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 18 May 2022.
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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 8-week mindfulness program in people with Mental Health Issue, run by The 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 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 18 May 2022. 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?
Change in General Health (time frame: Baseline, Immediately after intervention, Two-months after intervention). 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 18 May 2022.