- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623438
Self-administered Acupressure for Insomnia Disorder
Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- School of Nursing, the Hong Kong Polytechnic University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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/
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-administered acupressure group
Subjects will attend two weekly 120-minute of self-administered acupressure training
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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.
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Active Comparator: Sleep hygiene education (SHE) group
Subjects will attend two weekly 120-minute of sleep hygiene education
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI)
Time Frame: Week 8
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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.
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Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 7-day daily sleep diary
Time Frame: Baseline, Week 4, Week8
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The standardized sleep diary records the daily sleep parameters.
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Baseline, Week 4, Week8
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, Week 4, Week8
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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.
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Baseline, Week 4, Week8
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The 7-day actigraphy
Time Frame: Baseline, Week 4, Week8
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An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity.
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Baseline, Week 4, Week8
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Short Form- 6 Dimensions
Time Frame: Baseline, Week 4, Week8
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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.
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Baseline, Week 4, Week8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility of Treatment Rating Scale
Time Frame: Baseline
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The 4-item Credibility of Treatment Rating Scale will be used to assess subjects' expectation towards the intervention in both groups.
The score of each item will be reported.
The score of each item ranges from 1 to 6.
A higher score indicates a higher confidence toward the intervention.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelfAcupInsomnia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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