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Self-administered Acupressure for Insomnia Disorder

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Insomnia Chronic

Treatments

Behavioral: Sleep hygiene education (SHE) group
Behavioral: Self-administered acupressure group

Study type

Interventional

Funder types

Other

Identifiers

NCT03623438
SelfAcupInsomnia

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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/

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Self-administered acupressure group
Experimental group
Description:
Subjects will attend two weekly 120-minute of self-administered acupressure training
Treatment:
Behavioral: Self-administered acupressure group
Sleep hygiene education (SHE) group
Active Comparator group
Description:
Subjects will attend two weekly 120-minute of sleep hygiene education
Treatment:
Behavioral: Sleep hygiene education (SHE) group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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