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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors are unaware of the group allocation.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 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.
次要结局
- 7-day Actigraphy(3-month follow-up and 15-month follow-up)
- Sleep Medication Record(3-month follow-up and 15-month follow-up)
- Mental Health by Hospital Anxiety and Depression Scale (HADS)(3-month follow-up and 15-month follow-up)
- Dietary Intake(3-month follow-up and 15-month follow-up)
- 7-day Sleep Diary(3-month follow-up and 15-month follow-up)
- Quality of Life by Standard SF-12 Health Survey (SF12v2)(3-month follow-up and 15-month follow-up)
- Balance and Lower Extremity Function by Short Physical Performance Battery (SPPB)(3-month follow-up and 15-month follow-up)
- Adverse Events(3-month follow-up and 15-month follow-up)
- 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)
- Pittsburgh Sleep Quality Index (PSQI)(3-month follow-up and 15-month follow-up)
- Habitual Physical Activity(3-month follow-up and 15-month follow-up)
研究者
Parco M. Siu, PhD
Associate Professor and Division Head
The University of Hong Kong