Self-acupressure for Insomnia

Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia; Acupressure
• Intervention / Treatment: Other: Self-acupressure; Other: Sleep hygiene education

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Nursing, The Hong Kong Polytechnic University
    • Contact: Wing-Fai Yeung; Email: jerry-wf.yeung@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 7-day daily sleep diary	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%).	7 days
Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms.	7 days
Short Form-6D (SF-6D)	SF-6D is composed of six multi-level dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality.	4 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Wing-Fai Yeung, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): March 3, 2017
• Study Completion (Anticipated): March 31, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Insomnia; Acupressure; Self-help
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HSEAR 20161123005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No