InsomniaNCT06910423
Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia
A study testing Psychosocial intervention in people with Insomnia and Randomised Controlled Trial, run by College of Professional and Continuing Education Limited at 1 site in Hong Kong.
Trial summary
This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Randomised Controlled Trial
- What is being tested?
- Psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2030to 31 Dec 2032
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) being a resident of Hong Kong;
- (2) age between 50 and 75 years old;
- (3) possessing the ability to read and write in Chinese;
- (4) obtaining a Pittsburgh Sleep Quality Index (PSQI) score > 5 at baseline
- (5) demonstrating willingness to provide informed consent and adherence to study protocol.
Who cannot join
- (1) Beck Depression Inventory-II suicidal ideation score >= 2;
- (2) current use of hypnotic medications or any prescription medications that may influence sleep;
- (3) necessity to take such medications during the trial period;
- (4) ongoing therapies or clinical trials for insomnia;
- (5) intention to undergo such clinical interventions during the trial period;
- (6) working in shifts;
Show all 14Show fewer
- (7) engagement in considerable mindfulness practices exceeding 15 minutes per day;
- (8) regular participation in different forms of Qigong, aerobics, yoga, Tai Chi, or martial arts practice at least once a week in the past six months;
- (9) limited mobility or health conditions that hinder the performance of specific Qigong movements;
- (10) currently receiving psychological, psychiatric or counselling services at least once a month;
- (11) having been diagnosed with schizophrenia or psychosis by a clinician;
- (12) having an active metal implant, pacemaker, or defibrillator in the body that affects objective assessment;
- (13) impaired skin integrity or allergies to electrode gel or adhesive at the wearable EEG device placement site;
- (14) pregnancy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Division of Social Sciences, Humanities and Design
Hong Kong
About this study
Official title: Comparative Effectiveness of the Mahayana Buddhist Awareness Training Program and Qigong Intervention on the Psychological and Neurological Outcomes for People With Insomnia: A Randomized Controlled Trial
This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which these two Eastern mind body interventions improve sleep quality. It is expected that ATP will be as efficacious as Qigong in enhancing sleep quality. Compared to the Qigong intervention, the more mind-based ATP will lead to more improvement in mental health and greater reductions in hyperarousal brain activity. Compared to ATP, the more body-based Qigong will lead to greater improvement in physical health and heart rate variability.
- Conditions
- Insomnia, Randomised Controlled Trial
- Being tested
- Psychosocial intervention
- Keywords
- Mahayana Buddhist Awareness Training Program, Electroencephalography, Qigong, Hong Kong
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
Culturally relevant psychosocial intervention for people with insomnia
| Study group | Role | What they receive |
|---|---|---|
| Mahayana Buddhist Awareness Training Program (ATP) | Experimental | The 8-session ATP intervention consists of six 3-hour workshops plus two full day retreats. It will be delivered by instructors, who are trained by ATP co-founders. Participants will be guided to cultivate wisdom of non-attachment and compassion progressively by learning, contemplation, and practice. They will learn and memorize a core Buddhist mantra "Om mani padme hum," attend lectures, practice meditation, participate in experiential and reflective learning activities, and join the group discussions. Each workshop will typically begin with a sharing session followed by a Q\&A segment to address participants' questions and concerns. To deepen their learning experience, revision exercises and corrections to revision exercises will be embedded at the end of each workshop. Participants will also receive guided meditation audio tracks, handouts, and weekly homework assignment to support their practice outside of workshop sessions. Receives: Behavioral: Psychosocial intervention |
| Qigong Intervention | Experimental | The 8-session Qigong intervention, with reference to the Five Elements Balance Qigong, will be delivered by instructors, who are trained by an experienced Daoist Qigong master teacher. It consists of six-3 hour workshops plus two full day retreats. Each workshop will typically begin with an introduction to some basic Traditional Chinese Medicine and Qigong concepts, or precautions in doing Qigong exercises and addressing participants' inquiries. Participants will progressively learn ten forms of simple Qigong movements that aim to enhance the flow of qi .The participants will also be asked to practice Qigong at home for 30 minutes at least three times per week and complete a practice log. Participants will also receive handouts to support their learning after each session. Receives: Behavioral: Psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
It measures sleep quality and disturbances experienced within a 1-month time frame. Scores range from 0 to 21, where a higher score represents poorer sleep quality.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the brain activity during wakefulness
Spectral power analysis for participants' theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-50 Hz) bands during a 10-minute resting state wakefulness will be measured by the UMindSleep device (http://www.eegsmart.com/en/UMindSleep.html).
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the heart rate variability
This will be measured by the same wearable UMindSleep device.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Secondary outcomes (9)
Changes over the measurement points in the 7-item Insomnia Severity Index
It measures the nature, severity and impact of insomnia. Scores range from 0 to 28, where a higher score represents greater insomnia severity.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 16-item Pre-Sleep Arousal Scale
It measures the symptoms of cognitive and somatic arousal experienced at bedtime. Scores range from 18 to 80, where a higher score represents greater pre-sleep arousal.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 5-item item Santa Clara Brief Compassion Scale
It measures participants' perceived compassion towards others. Scores ranges from 5 to 35, where a higher score represents greater compassion towards others.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the PROMIS® 2-item Global Physical Health-2 Scale
It measures participants' perceived physical health. The raw total score will be converted to a T-score. T scores range from 23.4 to 63.3, where a higher score represents a higher perceived physical health.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the PROMIS® 2-item Global Mental Health-2 Scale
It measures participants' perceived mental health. The raw total score will be converted to a T-score. T Scores ranges from 25.8 to 64.6, where a higher score represents a higher perceived mental health.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 6-item Qi Stagnation Scale
It measures participants' self-reported pathological qi status characterized by the slow and idle flow of qi. Scores range from 6 to 30, where a higher score represents greater qi stagnation.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 6-item Qi Deficiency Scale
It measures participants' self-reported pathological qi status characterized by the lack of qi in one of the viscera or the whole body. Scores range from 6 to 30, where a higher score represents greater qi deficiency.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 2-item Generalized Anxiety Disorder-2 Scale
It measures participants' anxiety level. Scores range from 0 to 6, where a higher score represents higher anxiety level.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 2-item Patient Health Questionnaire-2 Scale
It measures participants' depression level. Scores range from 0 to 6, where a higher score represents higher depression level.
Measured: Baseline, immediately after the intervention, 7 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Jan 2030 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Why it stopped: Funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Professional and Continuing Education Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Ka-Ying Dr. HUI, PhD, Principal investigator, College of Professional and Continuing Education Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910423
- Sponsor's protocol ID
- RC_ETH_H_274
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu BWY, Gao J, Leung HK, Sik HH. A randomized controlled trial of Awareness Training Program (ATP), a group based Mahayana Buddhist intervention. Mindfulness. 2019;10:1280 1293. https://doi.org/10.1007/s12671-018-1082-1
Ng SM, Yin MXC, Chan JSM, Chan CHY, Fong TCT, Li A, So KF, Yuen LP, Chen JP, Chung KF, Chan CLW. Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1beta: A three-arm randomized controlled trial for persons with sleep disturbance and depression. Brain Behav Immun. 2022 Jan;99:166-176. doi: 10.1016/j.bbi.2021.09.022. Epub 2021 Oct 8.
PubMed 34634445Lee KCG, Gao J, Leung HK, Wu BWY, Roberts A, Thach TQ, Sik HH. Modulating Consciousness through Awareness Training Program and Its Impacts on Psychological Stress and Age-Related Gamma Waves. Brain Sci. 2024 Jan 17;14(1):91. doi: 10.3390/brainsci14010091.
PubMed 38248306Gao J, Leung HK, Fan J, Wu BWY, Sik HH. The neurophysiology of the intervention strategies of Awareness Training Program on emotion regulation. Front Psychol. 2022 Jul 22;13:891656. doi: 10.3389/fpsyg.2022.891656. eCollection 2022.
PubMed 35936346Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31.
PubMed 23983785Chan CS, Wong CYF, Yu BYM, Hui VKY, Ho FYY, Cuijpers P. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial. Psychol Med. 2023 Apr;53(5):1799-1813. doi: 10.1017/S0033291721003421. Epub 2021 Aug 23.
PubMed 37310329
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the Mahayana Buddhist Awareness Training Program and Qigong Intervention on the Psychological and Neurological Outcomes for People With Insomnia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06910423
- Acronym / sponsor ID
- RC_ETH_H_274
- Conditions
- Insomnia, Randomised Controlled Trial
- Keywords
- Mahayana Buddhist Awareness Training Program, Electroencephalography, Qigong, Hong Kong
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding not available
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- College of Professional and Continuing Education LimitedUniversity, hospital or other
- Study start
- 1 Jan 2030 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 4 Apr 2025 (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.
This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which these two Eastern mind body interventions improve sleep quality. It is expected that ATP will be as efficacious as Qigong in enhancing sleep quality. Compared to the Qigong intervention, the more mind-based ATP will lead to more improvement in mental health and greater reductions in hyperarousal brain activity. Compared to ATP, the more body-based Qigong will lead to greater improvement in physical health and heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mahayana Buddhist Awareness Training Program (ATP) | Experimental | Behavioral: Psychosocial interventionThe 8-session ATP intervention consists of six 3-hour workshops plus two full day retreats. It will be delivered by instructors, who are trained by ATP co-founders. Participants will be guided to cultivate wisdom of non-attachment and compassion progressively by learning, contemplation, and practice. They will learn and memorize a core Buddhist mantra "Om mani padme hum," attend lectures, practice meditation, participate in experiential and reflective learning activities, and join the group discussions. Each workshop will typically begin with a sharing session followed by a Q\&A segment to address participants' questions and concerns. To deepen their learning experience, revision exercises and corrections to revision exercises will be embedded at the end of each workshop. Participants will also receive guided meditation audio tracks, handouts, and weekly homework assignment to support their practice outside of workshop sessions. |
| Qigong Intervention | Experimental | Behavioral: Psychosocial interventionThe 8-session Qigong intervention, with reference to the Five Elements Balance Qigong, will be delivered by instructors, who are trained by an experienced Daoist Qigong master teacher. It consists of six-3 hour workshops plus two full day retreats. Each workshop will typically begin with an introduction to some basic Traditional Chinese Medicine and Qigong concepts, or precautions in doing Qigong exercises and addressing participants' inquiries. Participants will progressively learn ten forms of simple Qigong movements that aim to enhance the flow of qi .The participants will also be asked to practice Qigong at home for 30 minutes at least three times per week and complete a practice log. Participants will also receive handouts to support their learning after each session. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) being a resident of Hong Kong;
- (2) age between 50 and 75 years old;
- (3) possessing the ability to read and write in Chinese;
- (4) obtaining a Pittsburgh Sleep Quality Index (PSQI) score > 5 at baseline
- (5) demonstrating willingness to provide informed consent and adherence to study protocol.
Key exclusion criteria (14 listed)
- (1) Beck Depression Inventory-II suicidal ideation score >= 2;
- (2) current use of hypnotic medications or any prescription medications that may influence sleep;
- (3) necessity to take such medications during the trial period;
- (4) ongoing therapies or clinical trials for insomnia;
- (5) intention to undergo such clinical interventions during the trial period;
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 |
|---|---|---|
| Psychosocial interventionCulturally relevant psychosocial intervention for people with insomnia | Behavioural | Mahayana Buddhist Awareness Training Program (ATP), Qigong Intervention |
Primary outcome
Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
It measures sleep quality and disturbances experienced within a 1-month time frame. Scores range from 0 to 21, where a higher score represents poorer sleep quality.
Changes over the measurement points in the brain activity during wakefulness
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Spectral power analysis for participants' theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-50 Hz) bands during a 10-minute resting state wakefulness will be measured by the UMindSleep device (http://www.eegsmart.com/en/UMindSleep.html).
Changes over the measurement points in the heart rate variability
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
This will be measured by the same wearable UMindSleep device.
9 secondary outcomes
Changes over the measurement points in the 7-item Insomnia Severity Index
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 16-item Pre-Sleep Arousal Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 5-item item Santa Clara Brief Compassion Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the PROMIS® 2-item Global Physical Health-2 Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the PROMIS® 2-item Global Mental Health-2 Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 6-item Qi Stagnation Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 6-item Qi Deficiency Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 2-item Generalized Anxiety Disorder-2 Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Changes over the measurement points in the 2-item Patient Health Questionnaire-2 Scale
Time frame: Baseline, immediately after the intervention, 7 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- BackgroundWu BWY, Gao J, Leung HK, Sik HH. A randomized controlled trial of Awareness Training Program (ATP), a group based Mahayana Buddhist intervention. Mindfulness. 2019;10:1280 1293. https://doi.org/10.1007/s12671-018-1082-1
- Background: PubMed 34634445Ng SM, Yin MXC, Chan JSM, Chan CHY, Fong TCT, Li A, So KF, Yuen LP, Chen JP, Chung KF, Chan CLW. Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1beta: A three-arm randomized controlled trial for persons with sleep disturbance and depression. Brain Behav Immun. 2022 Jan;99:166-176. doi: 10.1016/j.bbi.2021.09.022. Epub 2021 Oct 8.
- Background: PubMed 38248306Lee KCG, Gao J, Leung HK, Wu BWY, Roberts A, Thach TQ, Sik HH. Modulating Consciousness through Awareness Training Program and Its Impacts on Psychological Stress and Age-Related Gamma Waves. Brain Sci. 2024 Jan 17;14(1):91. doi: 10.3390/brainsci14010091.
- Background: PubMed 35936346Gao J, Leung HK, Fan J, Wu BWY, Sik HH. The neurophysiology of the intervention strategies of Awareness Training Program on emotion regulation. Front Psychol. 2022 Jul 22;13:891656. doi: 10.3389/fpsyg.2022.891656. eCollection 2022.
- Background: PubMed 23983785Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31.
- Background: PubMed 37310329Chan CS, Wong CYF, Yu BYM, Hui VKY, Ho FYY, Cuijpers P. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial. Psychol Med. 2023 Apr;53(5):1799-1813. doi: 10.1017/S0033291721003421. Epub 2021 Aug 23.
- Individual participant dataSharing planned: No
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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.
Victoria Ka-Ying Dr. HUI, PhD principal investigator
College of Professional and Continuing Education Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention in people with Insomnia and Randomised Controlled Trial, run by College of Professional and Continuing Education Limited 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 5 inclusion and 14 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: paused, as of the sponsor's last update on 19 Mar 2026. 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?
Results are not available in the source record.
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?
Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index (time frame: Baseline, immediately after the intervention, 7 weeks after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06910423, which also lists 6 linked publications.
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 19 Mar 2026.