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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.
Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, Hong Kong
Insomnia Severity Index (ISI)
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.
Time frame: Week 8
The 7-day daily sleep diary
The standardized sleep diary records the daily sleep parameters.
Time frame: Baseline, Week 4, Week8
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-administrated questionnaire, which assesses the severity of depressive and anxiety symptoms. The anxiety and depression subscore will be reported. The subscore ranges from 0 to 21; a higher score indicates a more severe condition.
Time frame: Baseline, Week 4, Week8
The 7-day actigraphy
An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity.
Time frame: Baseline, Week 4, Week8
Short Form- 6 Dimensions
It is a preference-based measure of health derived from the Short Form-36. It includes six dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality. The total score will be reported. The score ranges from 0 to 1; a higher score indicates a better outcome.
Time frame: Baseline, Week 4, Week8
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