Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia

March 17, 2026 updated by: College of Professional and Continuing Education Limited

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Division of Social Sciences, Humanities and Design

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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;
  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mahayana Buddhist Awareness Training Program (ATP)
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.
Behavioral: Psychosocial intervention
Culturally relevant psychosocial intervention for people with insomnia
Experimental: Qigong Intervention
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.
Behavioral: Psychosocial intervention
Culturally relevant psychosocial intervention for people with insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately after the intervention, 7 weeks after the intervention
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).
Baseline, immediately after the intervention, 7 weeks after the intervention
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.
Baseline, immediately after the intervention, 7 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes over the measurement points in the 7-item Insomnia Severity Index
Time Frame: Baseline, immediately after the intervention, 7 weeks after the intervention
It measures the nature, severity and impact of insomnia. Scores range from 0 to 28, where a higher score represents greater insomnia severity.
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
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.
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
It measures participants' perceived compassion towards others. Scores ranges from 5 to 35, where a higher score represents greater compassion towards others.
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
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.
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
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.
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
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.
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
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.
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
It measures participants' anxiety level. Scores range from 0 to 6, where a higher score represents higher anxiety level.
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
It measures participants' depression level. Scores range from 0 to 6, where a higher score represents higher depression level.
Baseline, immediately after the intervention, 7 weeks after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Baseline
Single items will be used to measure participants' age, education level, marital status, occupation, gender, presence of chronic illness, presence of life-threatening illness, and perceived energy levels throughout the day.
Baseline
Treatment Acceptance
Time Frame: Immediately after the intervention
This will be measured by two self-constructed items, namely, perceived helpfulness of the intervention and perceived appropriateness of the intervention content, on a 5-point Likert scale. Scores range from 2 to 10, where a higher score represents a higher treatment acceptance.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

College of Professional and Continuing Education Limited

Investigators

  • Principal Investigator: Victoria Ka-Ying Dr. HUI, PhD, College of Professional and Continuing Education Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2030

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC_ETH_H_274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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