Self-acupressure for Insomnia

Insomnia Clinical Trial

Official title:

Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053648
• Other study ID #: HSEAR 20161123005
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2017
• Last updated: February 14, 2017
• Start date: December 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: February 2017
• Source: The Hong Kong Polytechnic University
• Contact: Wing-Fai Yeung
• Email: jerry-wf.yeung[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acupressure
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, the Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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