Self-administered Acupressure for Insomnia Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Behavioral: Self-administered acupressure group
* Behavioral: Sleep hygiene education (SHE) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months; Pregnancy; 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/

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered acupressure group<br>Subjects will attend two weekly 120-minute of self-administered acupressure training | Behavioral: Self-administered acupressure group<br>* 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.<br>|
| Active Comparator: Sleep hygiene education (SHE) group<br>Subjects will attend two weekly 120-minute of sleep hygiene education | Behavioral: Sleep hygiene education (SHE) group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 7-day daily sleep diary | The standardized sleep diary records the daily sleep parameters. | 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. | Baseline, Week 4, Week8 | 
| The 7-day actigraphy | An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity. | 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. | Baseline, Week 4, Week8 |