Clinical trial NCT03623438: Self-administered Acupressure for Insomnia Disorder
Official title: Self-administered Acupressure for Insomnia Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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/

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Week 8
Secondary outcomes:
measure: The 7-day daily sleep diary
timeFrame: Baseline, Week 4, Week8
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Week 4, Week8
measure: The 7-day actigraphy
timeFrame: Baseline, Week 4, Week8
measure: Short Form- 6 Dimensions
timeFrame: Baseline, Week 4, Week8
Other outcomes:
measure: Credibility of Treatment Rating Scale
timeFrame: Baseline
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
References: