Self-acupressure for Insomnia

Not Applicable

• Conditions: Acupressure; Insomnia

• Registration Number: NCT03053648
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-16
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• (1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
• (2) Aged 18 - 65 years;
• (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.)
• (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; and
• (6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

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