Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled 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
The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.
详细描述
Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.
Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE 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-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
- •Aged 18-64 years;
- •A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
- •Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
- •Willing to give informed consent and comply with the trial protocol.
排除标准
- •Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
- •Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
- •At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
- •No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
- •Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
- •Shift-workers/
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Week 8
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, distress and functional impairment associated with insomnia on a 5-point Likert scale. The total score will be reported. The score ranges from 0 to 28; a higher score indicates a more severe condition.
次要结局
- The 7-day daily sleep diary(Baseline, Week 4, Week8)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, Week 4, Week8)
- The 7-day actigraphy(Baseline, Week 4, Week8)
- Short Form- 6 Dimensions(Baseline, Week 4, Week8)