Self-acupressure for Insomnia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Self-acupressure Group Subjects in this group will attend two weekly 120-minute self-acupressure training sessions in a classroom at the School of Nursing, the Hong Kong Polytechnic University. The subjects will be instructed on how to perform the self-acupressure treatment by a trained instructor. To enhance interaction and ensure the quality of teaching, each course will be conducted in a small group of 6 participants. Subjects will perform self-acupressure daily for 4 consecutive weeks. |
Other: Self-acupressure
The subjects will be told to perform self-acupressure 30 min before sleep for 20 min every night for 4 weeks. Telephone follow-up will be made twice a week by the trained student research assistant during the 4-week treatment period to remind subjects to practice self-acupressure.
|
| Active Comparator: Sleep Hygiene Education Group To control the contact time with professional person in the treatment group, participants in this group will receive two sessions of 120-minute sleep hygiene training session. The participants will be asked to follow the health hygiene instructions daily for 4 consecutive weeks. |
Other: Sleep hygiene education
A training hand-out will be provided to each subject. The hand-outs included manualized sleep hygiene instructions. A registered nurse who has been trained by a clinical psychologist will be the instructor on sleep hygiene and activity scheduling. To enhance interaction and ensure the quality of teaching, each course will be conducted in a group of 5 participants.
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity Index (ISI) [7 days]
The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale.
Secondary Outcome Measures
- The 7-day daily sleep diary [7 days]
The standardized sleep diary records the bedtime and rising time, from which the total time in bed (TIB) can be calculated. Subjects will be asked to estimate sleep-onset latency, wake after sleep onset, and total sleep time (TST). Sleep efficiency will be calculated as (TST/TIB * 100%).
- Hospital Anxiety and Depression Scale (HADS) [7 days]
The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms.
- Short Form-6D (SF-6D) [4 weeks]
SF-6D is composed of six multi-level dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
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(2) Aged 18 - 65 years;
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(3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
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(4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
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(5) Willing to give informed consent and comply with the trial protocol.
Exclusion Criteria:
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(1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
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(2) Pregnancy;
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(3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23;
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(4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
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(5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
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(6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | School of Nursing, the Hong Kong Polytechnic University | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
- Principal Investigator: Wing-Fai Yeung, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSEAR 20161123005