Self-acupressure for Insomnia

The Hong Kong Polytechnic University

Status: Unknown

Conditions: Acupressure; Insomnia

Treatments: Other: Sleep hygiene education; Other: Self-acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03053648

HSEAR 20161123005

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Self-acupressure Group

Experimental group

Description:

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.

Treatment:

Other: Self-acupressure

Sleep Hygiene Education Group

Active Comparator group

Description:

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.

Treatment:

Other: Sleep hygiene education