Self-acupressure for Insomnia

Not Applicable

• Conditions: Acupressure; Insomnia
• Interventions: Other: Sleep hygiene education; Other: Self-acupressure

• 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

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Education Group	Sleep hygiene education	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.
Self-acupressure Group	Self-acupressure	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.

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