Self-administered Acupressure for Insomnia Disorder

NCT ID: NCT03623438

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-01-12

Brief Summary

The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.

Detailed Description

Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.

Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.

Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE 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-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.

Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.

Conditions

Insomnia Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-administered acupressure group

Subjects will attend two weekly 120-minute of self-administered acupressure training

Group Type: EXPERIMENTAL

Self-administered acupressure group

Intervention Type: BEHAVIORAL

Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.

Sleep hygiene education (SHE) group

Subjects will attend two weekly 120-minute of sleep hygiene education

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education (SHE) group

Intervention Type: BEHAVIORAL

Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.

Interventions

Self-administered acupressure group

Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.

Intervention Type: BEHAVIORAL

Sleep hygiene education (SHE) group

Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;

2. Aged 18-64 years;

3. A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)

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;

6. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and

7. Shift-workers/

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

SelfAcupInsomnia

Identifier Type: -

Identifier Source: org_study_id