Efficacy of Tai Chi Versus CBT-I in Treating Chronic Insomnia in Older Adults

NCT04384822 | Completed DMC

• 1 other identifier: 303005RF-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Insomnia

Keywords

Clinical Efficacy, Chronic Insomnia, Tai Chi, CBT-I

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  15-month follow-up

Secondary Outcomes (12)

• Remission of Chronic Insomnia-Semi-Structured Interview

  3-month follow-up and 15-month follow-up

• Treatment Response-Insomnia Severity Index (ISI)

  3-month follow-up and 15-month follow-up

• 7-day Actigraphy

  3-month follow-up and 15-month follow-up

• 7-day Sleep Diary

  3-month follow-up and 15-month follow-up

• Pittsburgh Sleep Quality Index (PSQI)

  3-month follow-up and 15-month follow-up

Study Arms (2)

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.

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.

Behavioral: CBT-I Group

Interventions

Tai Chi Group BEHAVIORAL

Mind-body exercise intervention

Tai Chi Group

CBT-I Group BEHAVIORAL

First-line clinically recommended non-pharmacological treatment of insomnia

CBT-I Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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),
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 41297969 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ming Fai P. Siu, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors are unaware of the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Division Head

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: May 12, 2020
• Study Start: June 1, 2020
• Primary Completion: October 27, 2023
• Study Completion: November 2, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years following the publication of the article
• Access Criteria: 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.

Locations

HK (1)