Effectiveness of short-term audio mindfulness in the Chinese community: a pilot study
| ISRCTN | ISRCTN16205138 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16205138 |
- Submission date
- 23/02/2021
- Registration date
- 26/02/2021
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Mindfulness is paying more attention to the present moment – to your own thoughts and feelings, and to the world around you. Becoming more aware of the present moment can help us enjoy the world around us more and understand ourselves better. When we become more aware of the present moment, we begin to experience afresh things that we have been taking for granted.
This is a study to test the effectiveness of a short-term audio mindfulness meditation (SAM) program for reducing signs of negative emotions in Chinese community-dwelling people during the period of COVID-19.
Who can participate?
Community-dwelling adults in mainland China will be recruited online.
What does the study involve?
Participants will be randomly allocated to the mindfulness meditation group or a waiting list control group. In the mindfulness group, participants will spend 10 to 20 minutes listening to the audio contents and practice daily mindfulness exercises throughout 3-week with a total of 21 sessions. At day 7, 14 and 21, participants will complete questionnaires to assess mental well being. After 21 days, the control group will also receive the meditation recordings.
What are the possible benefits and risks of participating?
This study will provide evidence to support a cost-effective and efficacious SAM program for community-dwelling people in mainland China during the epidemic period when face-to-face intervention is not feasible. Potential risks vary from person to person. Studies showing mindfulness may produce side effects of false memory and burnout.
Where is the study run from?
Department of Social Work at Hong Kong Baptist University (China)
When is the study starting and how long is it expected to run for?
October 2020 to July 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Joshua Nan, joshuanan@hkbu.edu.hk
Contact information
Scientific
Room AAB1012A, 10/F
Academic and Administration Building
15 Baptist University Road
Baptist University Road Campus
Hong Kong Baptist University
Kowloon Tong, KLN
Hong Kong
999077
China
 ORCID ID |
0000-0003-4840-6539 |
|---|---|
| Phone | +852 34112009 |
| joshuanan@hkbu.edu.hk |
Scientific
Room DLB701, 7/F
David C Lam Building
15 Baptist University Road
Baptist University Road Campus
Hong Kong Baptist University
Kowloon Tong, KLN
Hong Kong
999077
China
| ORCID ID |
0000-0002-3784-734X |
|---|---|
| Phone | +852 34112485 |
| 20481985@life.hkbu.edu.hk |
Study information
| Study design | Multicenter interventional non-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effectiveness and moderated mediation of short-term audio mindfulness for Chinese community-dwelling people: a randomized controlled trial |
| Study acronym | MMCRCT |
| Study hypothesis | The primary hypothesis is that negative emotions (anxiety, depression, stress, and negative affect) of community-dwelling people in mainland China will be reduced after mindfulness intervention and there are the potential mediation and moderation effect of anxiety through intervention effects on negative affectivity. Secondary hypotheses include positive emotions assessed, such as well-being, positive affect and mindfulness level, will be improved after the intervention. |
| Ethics approval(s) | Approved 18/02/2021, Research Ethics Committee of Hong Kong Baptist University (Graduate School, Hong Kong Baptist University, Kowloon Tong, Hong Kong; no telephone number provided; hkbu_rec@hkbu.edu.hk), ref: REC/20-21/0270 |
| Condition | Improvement of mental health in Chinese community-dwelling people during COVID-19 period |
| Intervention | Community-dwelling adults in mainland China will be recruited online and will be randomized using a computer-generated random number into an online audio-mindfulness meditation program and a waitlist control group. In the mindfulness group, participants will spend 10 to 20 minutes listening to the audio contents and practice daily mindfulness exercises throughout 3-week with a total of 21 sessions. They will fill in the scales about negative emotions (anxiety, depression, stress, and negative affect) four times (at baseline, 1-week, 2-week, and 3-week). Participants in the waitlist control group will need to fill in the same scales as the intervention group twice (at baseline and 3-week) and they will receive the same audio-mindfulness program for self-practice after all data collection procedures in the mindfulness group will be completed. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Stress will be measured using the Chinese version of the Perceived Stress Scale (CPSS) at baseline, 7-days, 14-days, and 21-days 2. Anxiety and depression will be measured using the Chinese Hospital Anxiety and Depression scale (HADS) at baseline, 7-days, 14-days, and 21-days 3. Negative affect will be measured using Positive and Negative Affect Schedule (PANAS) at baseline, 7-days, 14-days, and 21-days |
| Secondary outcome measures | 1. Well-being will be measured using the World Health Organization 5-item Well Being Index (WHO-5) at baseline, 7-days, 14-days, and 21-days 2. Mindfulness will be measured using the Freiburg Mindfulness Inventory (FMI) at baseline, 7-days, 14-days, and 21-days 3. Positive affect will be measured using Positive and Negative Affect Schedule (PANAS) at baseline, 7-days, 14-days, and 21-days |
| Overall study start date | 03/10/2020 |
| Overall study end date | 01/07/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 participants will be recruited and randomized into an online audio-mindfulness meditation program (n=70) and a waitlist control group (n=70). |
| Total final enrolment | 100 |
| Participant inclusion criteria | 1. Adults over 18 years old 2. Can understand and read Mandarin. 3. Have a smartphone with consistent internet access and can receive audio from the researcher every day 4. Have spare time to listen to audio for 10-15 minutes every day for 21 consecutive days |
| Participant exclusion criteria | 1. Practiced mindfulness mediation before 2. Receive any medication or psychotherapy currently 3. Have been diagnosed with depression, anxiety, or other mental illness |
| Recruitment start date | 15/03/2021 |
| Recruitment end date | 01/05/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Hong Kong
999077
China
Sponsor information
University/education
Graduate School
Kowloon Tong
Hong Kong
999077
China
| Phone | +852 3411–5127 |
|---|---|
| hkbu_rec@hkbu.edu.hk | |
| Website | http://buwww.hkbu.edu.hk/eng/main/index.jsp |
"ROR" |
https://ror.org/0145fw131 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 28/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal which would share participant-level data as required by the WHO and ICMJE. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 26/02/2021 | No | No | ||
| Basic results | 10/01/2022 | 10/01/2022 | No | No | |
| Results article | 30/11/2022 | 06/12/2022 | Yes | No | |
| Results article | Effects and mechanisms | 23/12/2022 | 04/06/2024 | Yes | No |
Additional files
- ISRCTN16205138_PROTOCOL.pdf
- uploaded 26/02/2021
- 39512 BasicResults 10Jan2022.pdf
Editorial Notes
04/06/2024: Publication reference added.
06/12/2022: Publication reference added.
10/01/2022: The basic results have been uploaded as an additional file.
02/09/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/09/2021 to 01/07/2021 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/09/2022 to 28/07/2021.
18/05/2021: The total final enrolment was changed from 140 to 100.
04/05/2021: The final enrolment number has been added.
26/02/2021: Uploaded protocol (not peer reviewed) Version n/a, 26 February 2021.
25/02/2021: Trial’s existence confirmed by Research Ethics Committee of Hong Kong Baptist University
