Insomnia Chronic Clinical Trial
Official title:
Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial
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.
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. Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated. Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model. ;
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