Self-acupressure for Insomnia

NCT03053648 | Unknown

• 1 other identifier: HSEAR 20161123005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Acupressure

Keywords

Insomnia; Randomized controlled trial; Acupressure; Self-help

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The 7-day daily sleep diary

  7 days

• Hospital Anxiety and Depression Scale (HADS)

  7 days

• Short Form-6D (SF-6D)

  4 weeks

Study Arms (2)

Self-acupressure Group

EXPERIMENTAL

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

Sleep Hygiene Education Group

ACTIVE COMPARATOR

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

Interventions

Self-acupressure OTHER

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.

Self-acupressure Group

Sleep hygiene education OTHER

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.

Sleep Hygiene Education Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Wing-Fai Yeung

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing-Fai Yeung

CONTACT

jerry-wf.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All of the assessments in this study will be self-completed. The researchers who perform the assessment and analysis will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: December 1, 2016
• Primary Completion: March 3, 2017
• Study Completion: March 31, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

HK (1)