The Efficacy of Cognitive Behavioral Therapy (CBT) and Acupressure for Insomnia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Insomnia Severity Index
研究概览
简要总结
This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation. CBT-I is widely used in western countries but it fails to address patient preference among Chinese adults with insomnia, as demonstrated in a previous study examining the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of psychological interventions for insomnia, integrative medicine with a combination of CBT-I and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of their combination.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents who are able to communicate in Cantonese;
- •Aged ≥ 18 years;
- •A current clinical DSM-5 diagnosis of insomnia disorder according to the Sleep Condition Indicator (SCI) ≥ 21;
- •Insomnia Severity Index (ISI) score ≥ 8; and
- •Willing to give informed consent and comply with the trial protocol.
排除标准
- •Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 ;
- •Receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure treatment for insomnia in the past 6 months;
- •Pregnancy; and
- •Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment.
结局指标
主要结局
Change in Insomnia Severity Index
时间窗: Pre-treatment, 1-week post-treatment and 4-week post treatment
A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
- Change in Multidimensional Fatigue Inventory (MFI)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
- Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
- Change in 7-Day Sleep Diary(Pre-treatment, 1-week post-treatment and 4-week post treatment)
- Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong