Clinical trial NCT04384822: Efficacy of Tai Chi Versus CBT-I in Treating Chronic Insomnia in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Clinical Efficacy, Chronic Insomnia, Tai Chi, CBT-I
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 3-month follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: 15-month follow-up
Secondary outcomes:
measure: Remission of Chronic Insomnia-Semi-Structured Interview
timeFrame: 3-month follow-up and 15-month follow-up
measure: Treatment Response-Insomnia Severity Index (ISI)
timeFrame: 3-month follow-up and 15-month follow-up
measure: 7-day Actigraphy
timeFrame: 3-month follow-up and 15-month follow-up
measure: 7-day Sleep Diary
timeFrame: 3-month follow-up and 15-month follow-up
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3-month follow-up and 15-month follow-up
measure: Sleep Medication Record
timeFrame: 3-month follow-up and 15-month follow-up
measure: Quality of Life by Standard SF-12 Health Survey (SF12v2)
timeFrame: 3-month follow-up and 15-month follow-up
measure: Mental Health by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3-month follow-up and 15-month follow-up
measure: Balance and Lower Extremity Function by Short Physical Performance Battery (SPPB)
timeFrame: 3-month follow-up and 15-month follow-up
measure: Adverse Events
timeFrame: 3-month follow-up and 15-month follow-up
measure: Habitual Physical Activity
timeFrame: 3-month follow-up and 15-month follow-up
measure: Dietary Intake
timeFrame: 3-month follow-up and 15-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Public Health, The University of Hong Kong
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Ming Fai P. Siu, PhD
role: PRINCIPAL_INVESTIGATOR
References: