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

NCT ID: NCT04384822

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-11-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tai Chi Group

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.

Group Type: EXPERIMENTAL

Tai Chi Group

Intervention Type: BEHAVIORAL

Mind-body exercise intervention

CBT-I Group

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.

Group Type: ACTIVE_COMPARATOR

CBT-I Group

Intervention Type: BEHAVIORAL

First-line clinically recommended non-pharmacological treatment of insomnia

Interventions

Tai Chi Group

Mind-body exercise intervention

Intervention Type: BEHAVIORAL

CBT-I Group

First-line clinically recommended non-pharmacological treatment of insomnia

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 50 years or older,

2. ethnic Chinese who can communicate by Cantonese or Mandarin, and

3. 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.

Exclusion Criteria

1. cannot walk without assistive device (e.g., cane),

2. somatic conditions that limit exercise participation (e.g., limb loss),

3. regular aerobic exercise or mind-body training such as tai chi, yoga, qigong or meditation (>3 times weekly for >60 minutes per session),

4. serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases),

5. dementia or use of anti-dementia medication,

6. under treatment for serious diseases known to affect sleep (e.g., cancer chemotherapy),

7. any chronic pain disorders known to affect sleep,

8. 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),

9. having current or past CBT-I,

10. shift-worker.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Parco M. Siu, PhD

Associate Professor and Division Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Fai P. Siu, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, The University of Hong Kong

Locations

School of Public Health, The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

303005RF-002

Identifier Type: -

Identifier Source: org_study_id