Self-administered Acupressure for Insomnia Disorder

Insomnia Chronic Clinical Trial

Official title:

Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623438
• Other study ID #: SelfAcupInsomnia
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 12, 2021

Study information

• Verified date: October 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 12, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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/

Related Conditions & MeSH terms

• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.

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
Other	Credibility of Treatment Rating Scale	The 4-item Credibility of Treatment Rating Scale will be used to assess subjects' expectation towards the intervention in both groups. The score of each item will be reported. The score of each item ranges from 1 to 6. A higher score indicates a higher confidence toward the intervention.	Baseline
Primary	Insomnia Severity Index (ISI)	The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, distress and functional impairment associated with insomnia on a 5-point Likert scale. The total score will be reported. The score ranges from 0 to 28; a higher score indicates a more severe condition.	Week 8
Secondary	The 7-day daily sleep diary	The standardized sleep diary records the daily sleep parameters.	Baseline, Week 4, Week8
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item self-administrated questionnaire, which assesses the severity of depressive and anxiety symptoms. The anxiety and depression subscore will be reported. The subscore ranges from 0 to 21; a higher score indicates a more severe condition.	Baseline, Week 4, Week8
Secondary	The 7-day actigraphy	An actigraph is a watch-like device used to estimate sleep-wake schedules by measuring activity.	Baseline, Week 4, Week8
Secondary	Short Form- 6 Dimensions	It is a preference-based measure of health derived from the Short Form-36. It includes six dimensions: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality. The total score will be reported. The score ranges from 0 to 1; a higher score indicates a better outcome.	Baseline, Week 4, Week8