Insomnia Clinical Trial
Official title:
Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
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.
n/a
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