Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Abstract
Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course.
Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks.
Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.
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
All of the assessments in this study will be self-completed. The researchers who perform the assessment and analysis will be blinded to group allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- •(2) Aged 18 - 65 years;
- •(3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
- •(4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- •(5) Willing to give informed consent and comply with the trial protocol.
排除标准
- •(1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- •(2) Pregnancy;
- •(3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23;
- •(4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
- •(5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
- •(6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 7 days
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.
次要结局
- Short Form-6D (SF-6D)(4 weeks)
- The 7-day daily sleep diary(7 days)
- Hospital Anxiety and Depression Scale (HADS)(7 days)