Chronic InsomniaNCT04384822
Efficacy of Tai Chi Versus CBT-I in Treating Chronic Insomnia in Older Adults
A study testing Tai Chi Group and CBT-I Group in people with Chronic Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Insomnia is common in the older population, over 50% of older adults have sleep complaints, and 20-40% are reported to have insomnia. In HK, 38% of adults have reported insomnia. Insomnia is associated with increased mortality and morbidity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Tai Chi Group and CBT-I Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2020to 2 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years or older,
- ethnic Chinese who can communicate by Cantonese or Mandarin, and
- fulfill the DSM-5 criteria for chronic insomnia including difficulty in initiating sleep, maintaining sleep or non-restorative sleep, with complaints of impaired daytime functioning, sleep difficulty occurring at least three nights per week present for at least 3 months.
Who cannot join
- cannot walk without assistive device (e.g., cane),
- somatic conditions that limit exercise participation (e.g., limb loss),
- regular aerobic exercise or mind-body training such as tai chi, yoga, qigong or meditation (>3 times weekly for >60 minutes per session),
- serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases),
- dementia or use of anti-dementia medication,
- under treatment for serious diseases known to affect sleep (e.g., cancer chemotherapy),
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- any chronic pain disorders known to affect sleep,
- untreated sleep disorder including obstructive sleep apnea, periodic leg movement disorder and narcolepsy (screened by questionnaire followed by polysomnographic confirmation in our Co-I's sleep lab, if needed),
- having current or past CBT-I,
- shift-worker.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Public Health, The University of Hong Kong
Hong Kong
About this study
Official title: Efficacy of Tai Chi Versus Cognitive Behavioral Therapy for Insomnia (CBT-I) to Treat Chronic Insomnia in Older Adults: A Randomized Controlled Non-inferiority Trial
Insomnia is common in the older population, over 50% of older adults have sleep complaints, and 20-40% are reported to have insomnia. In HK, 38% of adults have reported insomnia. Insomnia is associated with increased mortality and morbidity. As the worldwide population continues to age, insomnia in older adults will increasingly cause substantial economic burdens on healthcare systems and society.
Cognitive behavioral therapy for insomnia (CBT-I) is currently the first-line clinically recommended non-pharmacological treatment for insomnia in older persons. Our group has been actively studying the health-enhancing effects of tai chi. Tai chi has various health benefits including fall prevention, osteoarthritis management, cardiorespiratory fitness and improvement of sleep. In the present study, the investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. This study aims to exam whether three months of CBT-I or three months of tai chi have similar robust effects in treating insomnia in older adults.
Read more
The investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. The CBT-I and tai chi classes will be held twice a week with each lasting for 60 mins. The treatment is three months with 12-month follow-up.
The primary outcome of this study is the insomnia severity index (ISI) score at post-intervention measure, which examining sleep-onset and sleep maintenance difficulties, satisfaction with current sleep pattern, inference with daily functioning.
- Conditions
- Chronic Insomnia
- Being tested
- Tai Chi Group, CBT-I Group
- Keywords
- Clinical Efficacy, Chronic Insomnia, Tai Chi, CBT-I
- 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.
Tai Chi GroupBehavioural
Mind-body exercise intervention
CBT-I GroupBehavioural
First-line clinically recommended non-pharmacological treatment of insomnia
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Group | Experimental | Subjects will participate in a tai chi program conducted in small groups (10 subjects per group) delivered by qualified instructors, who have experience in teaching tai chi to older adults. The tai chi intervention will be prescribed as a 3-month program with two 1-hour sessions weekly. Tai chi forms will be taught for 2 months followed by 1 month of consolidation. The 24-form simplified Yang-style tai chi will be adopted, as it is the most popular form of tai chi and older adults can manage to learn this simplified form of tai chi within 2-3 months. The instructors will introduce the safety issues, proper training principles, and skills to the subjects in their first class to minimize any avoidable adverse events due to improper skill/practice. The appropriate intensity will be individually determined for each subject by the attending instructors to achieve the training principle of progressive adaptation regarding the exercise intensity. Receives: Behavioral: Tai Chi Group |
| CBT-I Group | Active comparator | Subjects will participate in a conventional CBT-I program conducted in small groups (10 subjects per group) delivered by trained personnel. The CBT-I will be prescribed as a 3-month program with two 1-hour sessions weekly. The CBT-I components will be delivered for 2 months, which is consistent with the duration of the majority of CBT-I treatments, followed by 1 month of consolidation. Receives: Behavioral: CBT-I Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
ISI will be used to assess the perceived insomnia severity. ISI has seven items examining sleep-onset and sleep maintenance difficulties, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment due to sleep problems, degree of distress, and concerns caused by sleep problems. All 160 participants will complete this subjective questionnaire in paper-pencil based manner.
Measured: 3-month follow-up
Insomnia Severity Index (ISI)
ISI will be used to assess the perceived insomnia severity. ISI has seven items examining sleep-onset and sleep maintenance difficulties, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment due to sleep problems, degree of distress, and concerns caused by sleep problems. All 160 participants will complete this subjective questionnaire in paper-pencil based manner.
Measured: 15-month follow-up
Secondary outcomes (12)
Remission of Chronic Insomnia-Semi-Structured Interview
The DSM-5 criteria for chronic insomnia will be used to assess the remission of chronic insomnia. All 160 participants will be led by research personnel to complete the brief insomnia questionnaire in a semi-structured interview.
Measured: 3-month follow-up and 15-month follow-up
Treatment Response-Insomnia Severity Index (ISI)
Treatment response is defined as a decrease in the Insomnia Severity Index (ISI) by at least 8 points, which indicates marked improvement or nearly complete or complete remission of insomnia symptoms.
Measured: 3-month follow-up and 15-month follow-up
7-day Actigraphy
A wrist actigraph (wGT3X-BT, Actigraph; a 3-axis accelerometer waterproof watch-like device) that detects movement or lack of movement correlating with wakefulness and sleep, respectively, will be used to objectively estimate sleep. All 160 participants will be instructed to wear an actigraph on the non-dominant wrist for 24 hours per day for 7 days. Actigraphic data will be analyzed by the ActiLifeV6.11.7 software to determine the sleep efficiency.
Measured: 3-month follow-up and 15-month follow-up
7-day Sleep Diary
All 160 participants will be instructed to record their sleep pattern each morning for 7 days using the provided log sheet that records information on bedtime, sleep rising time, total time in bed (TIB), sleep-onset latency (SOL), wake time after sleep onset (WASO), and total sleep time (TST). Sleep efficiency (SE) is estimated as TST/TIB x 100%.
Measured: 3-month follow-up and 15-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a standardized instrument to estimate sleep quantity and quality. There are 19 items that subjectively assess sleep quantity, perceived restfulness, and disturbance of sleep by gathering information on usual bedtime, wake time, time to fall asleep, time of actual sleep, and quality of sleep. All 160 participants will be asked to complete this questionnaire in paper-pencil based manner.
Measured: 3-month follow-up and 15-month follow-up
Sleep Medication Record
The use of sleep aid medications such as narcotics, antihistamines (diphenhydramine), benzodiazepines (e.g., flurazepam, etc), non-benzodiazepine, and benzodiazepine receptor agonists (e.g., zolpidem, etc) with detailed usage information (e.g., drug name, type, dose, and weekly frequency) will be recorded. All 160 participants will be asked to provide the dose and frequency of any sleep medications used by responding to a checklist of all available sleep medications. Data on medication dose and weekly frequency will be presented as the total number of lowest recommended dose (LRD) in 7 days.
Measured: 3-month follow-up and 15-month follow-up
Quality of Life by Standard SF-12 Health Survey (SF12v2)
The Chinese version SF-12, derived from the SF-36, will be used to measure health-related quality of life. There are 12 items assessing physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning, with higher overall scores indicating a better quality of life. The Chinese version SF- 12 has been validated in the Hong Kong Chinese population. All 160 participants will be asked to complete this questionnaire in paper-pencil based manner.
Measured: 3-month follow-up and 15-month follow-up
Mental Health by Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) will be used to evaluate the severity of depression and anxiety. This 7-item questionnaire has an overall score ranging from 0 to 21 (with subscales for both anxiety and depression), with a higher score indicating more severe symptoms. All 160 participants will be asked to complete this questionnaire in paper-pencil based manner.
Measured: 3-month follow-up and 15-month follow-up
Balance and Lower Extremity Function by Short Physical Performance Battery (SPPB)
SPPB will be used to assess balance and lower extremity function. SPPB includes repeated timed chair stands, timed standing balance (with feet in parallel, semi-tandem, and tandem positions), and a 4-meter walk to measure the usual gait speed. These outcomes will objectively validate the receipt of the tai chi intervention based on the known benefits of tai chi on balance and lower extremity performance. The investigators will assess the balance and lower extremity function during the baseline measurement.
Measured: 3-month follow-up and 15-month follow-up
Adverse Events
Adverse events (such as injuries related to interventions or not) will be closely monitored and recorded through regular surveys by instructors and research personnel, and by voluntary reports from the subjects. Subjects with sustained serious adverse events that affect their daily function will terminate the study, but their data will be included in our ITT analyses.
Measured: 3-month follow-up and 15-month follow-up
Habitual Physical Activity
Potential confounding factors including changes in habitual physical activity will be monitored. The habitual physical activity will be assessed by the international physical activity questionnaire and 7-day actigraph.
Measured: 3-month follow-up and 15-month follow-up
Dietary Intake
The diet will be assessed by a 3-day food diary. The research personnel will explain how to fill a 3-day food diary and all 160 participants will be asked to complete these 3 measurements
Measured: 3-month follow-up and 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jun 2020
- Primary completion27 Oct 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- Ming Fai P. Siu, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384822
- Sponsor's protocol ID
- 303005RF-002
- Status last verified
- Nov 2023
- First submitted
- 3 Apr 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
Publications
Siu PM, Yu DJ, Yu AP, Recchia F, Li SX, Chan RN, Fong DY, Chan DK, Hui SS, Chung KF, Woo J, Wang C, Irwin MR. Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial. BMJ. 2025 Nov 26;391:e084320. doi: 10.1136/bmj-2025-084320.
PubMed 41297969
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tai Chi Versus Cognitive Behavioral Therapy for Insomnia (CBT-I) to Treat Chronic Insomnia in Older Adults: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04384822
- Acronym / sponsor ID
- 303005RF-002
- Conditions
- Chronic Insomnia
- Keywords
- Clinical Efficacy, Chronic Insomnia, Tai Chi, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 12 May 2020 (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.
Insomnia is common in the older population, over 50% of older adults have sleep complaints, and 20-40% are reported to have insomnia. In HK, 38% of adults have reported insomnia. Insomnia is associated with increased mortality and morbidity. As the worldwide population continues to age, insomnia in older adults will increasingly cause substantial economic burdens on healthcare systems and society.
Cognitive behavioral therapy for insomnia (CBT-I) is currently the first-line clinically recommended non-pharmacological treatment for insomnia in older persons. Our group has been actively studying the health-enhancing effects of tai chi. Tai chi has various health benefits including fall prevention, osteoarthritis management, cardiorespiratory fitness and improvement of sleep. In the present study, the investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. This study aims to exam whether three months of CBT-I or three months of tai chi have similar robust effects in treating insomnia in older adults.
The investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. The CBT-I and tai chi classes will be held twice a week with each lasting for 60 mins. The treatment is three months with 12-month follow-up.
The primary outcome of this study is the insomnia severity index (ISI) score at post-intervention measure, which examining sleep-onset and sleep maintenance difficulties, satisfaction with current sleep pattern, inference with daily functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Group | Experimental | Behavioral: Tai Chi GroupSubjects will participate in a tai chi program conducted in small groups (10 subjects per group) delivered by qualified instructors, who have experience in teaching tai chi to older adults. The tai chi intervention will be prescribed as a 3-month program with two 1-hour sessions weekly. Tai chi forms will be taught for 2 months followed by 1 month of consolidation. The 24-form simplified Yang-style tai chi will be adopted, as it is the most popular form of tai chi and older adults can manage to learn this simplified form of tai chi within 2-3 months. The instructors will introduce the safety issues, proper training principles, and skills to the subjects in their first class to minimize any avoidable adverse events due to improper skill/practice. The appropriate intensity will be individually determined for each subject by the attending instructors to achieve the training principle of progressive adaptation regarding the exercise intensity. |
| CBT-I Group | Active comparator | Behavioral: CBT-I GroupSubjects will participate in a conventional CBT-I program conducted in small groups (10 subjects per group) delivered by trained personnel. The CBT-I will be prescribed as a 3-month program with two 1-hour sessions weekly. The CBT-I components will be delivered for 2 months, which is consistent with the duration of the majority of CBT-I treatments, followed by 1 month of consolidation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years or older,
- ethnic Chinese who can communicate by Cantonese or Mandarin, and
- fulfill the DSM-5 criteria for chronic insomnia including difficulty in initiating sleep, maintaining sleep or non-restorative sleep, with complaints of impaired daytime functioning, sleep difficulty occurring at least three nights per week present for at least 3 months.
Key exclusion criteria (10 listed)
- cannot walk without assistive device (e.g., cane),
- somatic conditions that limit exercise participation (e.g., limb loss),
- regular aerobic exercise or mind-body training such as tai chi, yoga, qigong or meditation (>3 times weekly for >60 minutes per session),
- serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases),
- dementia or use of anti-dementia medication,
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 |
|---|---|---|
| Tai Chi GroupMind-body exercise intervention | Behavioural | Tai Chi Group |
| CBT-I GroupFirst-line clinically recommended non-pharmacological treatment of insomnia | Behavioural | CBT-I Group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 3-month follow-up
ISI will be used to assess the perceived insomnia severity. ISI has seven items examining sleep-onset and sleep maintenance difficulties, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment due to sleep problems, degree of distress, and concerns caused by sleep problems. All 160 participants will complete this subjective questionnaire in paper-pencil based manner.
Insomnia Severity Index (ISI)
Time frame: 15-month follow-up
ISI will be used to assess the perceived insomnia severity. ISI has seven items examining sleep-onset and sleep maintenance difficulties, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment due to sleep problems, degree of distress, and concerns caused by sleep problems. All 160 participants will complete this subjective questionnaire in paper-pencil based manner.
12 secondary outcomes
Remission of Chronic Insomnia-Semi-Structured Interview
Time frame: 3-month follow-up and 15-month follow-up
Treatment Response-Insomnia Severity Index (ISI)
Time frame: 3-month follow-up and 15-month follow-up
7-day Actigraphy
Time frame: 3-month follow-up and 15-month follow-up
7-day Sleep Diary
Time frame: 3-month follow-up and 15-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3-month follow-up and 15-month follow-up
Sleep Medication Record
Time frame: 3-month follow-up and 15-month follow-up
Quality of Life by Standard SF-12 Health Survey (SF12v2)
Time frame: 3-month follow-up and 15-month follow-up
Mental Health by Hospital Anxiety and Depression Scale (HADS)
Time frame: 3-month follow-up and 15-month follow-up
Balance and Lower Extremity Function by Short Physical Performance Battery (SPPB)
Time frame: 3-month follow-up and 15-month follow-up
Adverse Events
Time frame: 3-month follow-up and 15-month follow-up
Habitual Physical Activity
Time frame: 3-month follow-up and 15-month follow-up
Dietary Intake
Time frame: 3-month follow-up and 15-month follow-up
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 30 Nov 2023.
- Derived from this study: PubMed 41297969Siu PM, Yu DJ, Yu AP, Recchia F, Li SX, Chan RN, Fong DY, Chan DK, Hui SS, Chung KF, Woo J, Wang C, Irwin MR. Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial. BMJ. 2025 Nov 26;391:e084320. doi: 10.1136/bmj-2025-084320.
- Individual participant dataSharing planned: Yes. The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
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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.
Ming Fai P. Siu, PhD principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Group and CBT-I Group in people with Chronic Insomnia, 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 10 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 30 Nov 2023. 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?
Insomnia Severity Index (ISI) (time frame: 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT04384822, which also lists 1 linked publication.
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 30 Nov 2023.