Self-administered Acupressure for Insomnia Disorder

Not Applicable

Completed

• Conditions: Insomnia Chronic

• Registration Number: NCT03623438
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-09-01
• Status Verified: 2019-10
• Primary Completion: 2020-08-30
• Study Completion: 2021-01-12
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
2. Aged 18-64 years;
3. A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
4. Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
5. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria

1. Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
2. Pregnancy;
3. Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
4. At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
5. No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
6. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
7. Shift-workers/

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Week 8	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.

Secondary Outcome Measures

Name	Time	Method
The 7-day daily sleep diary	Baseline, Week 4, Week8	The standardized sleep diary records the daily sleep parameters.
Hospital Anxiety and Depression Scale (HADS)	Baseline, Week 4, Week8	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.
The 7-day actigraphy	Baseline, Week 4, Week8	An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity.
Short Form- 6 Dimensions	Baseline, Week 4, Week8	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.

Trial Locations

Locations (1)

School of Nursing, the Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong