Self-administered Acupressure for Insomnia Disorder

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.

Inclusion criteria

• Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
• Aged 18-64 years;
• A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
• Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
• Willing to give informed consent and comply with the trial protocol.

Exclusion criteria

• Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
• Pregnancy;
• Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
• At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
• No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
• Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
• Shift-workers/