Insomnia, Randomised Controlled Trial
Conditions
Keywords
Mahayana Buddhist Awareness Training Program, Electroencephalography, Qigong, Hong Kong
Brief 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 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.
Interventions
BEHAVIORALPsychosocial intervention
Culturally relevant psychosocial intervention for people with insomnia
Sponsors
College of Professional and Continuing Education Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index | 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 | 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 | Baseline, immediately after the intervention, 7 weeks after the intervention | This will be measured by the same wearable UMindSleep device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes over the measurement points in the 7-item Insomnia Severity Index | 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. |
| Changes over the measurement points in the 16-item Pre-Sleep Arousal Scale | 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. |
| Changes over the measurement points in the 5-item item Santa Clara Brief Compassion Scale | 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. |
| Changes over the measurement points in the PROMIS® 2-item Global Physical Health-2 Scale | 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. |
| Changes over the measurement points in the PROMIS® 2-item Global Mental Health-2 Scale | 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. |
| Changes over the measurement points in the 6-item Qi Stagnation Scale | 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. |
| Changes over the measurement points in the 6-item Qi Deficiency Scale | 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. |
| Changes over the measurement points in the 2-item Generalized Anxiety Disorder-2 Scale | 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. |
| Changes over the measurement points in the 2-item Patient Health Questionnaire-2 Scale | 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORVictoria Ka-Ying Dr. HUI, PhD
College of Professional and Continuing Education Limited
Outcome results
None listed