Clinical trial NCT03053648: Self-acupressure for Insomnia
Official title: Self-acupressure for Insomnia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Acupressure
Keywords: Insomnia
Randomized controlled trial
Acupressure
Self-help
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abstract

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

Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks.

Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control 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-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice.

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

Data Analysis: Differences in the questionnaire scores, subjective 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 - 65 years;
* (3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
* (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; and
* (6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 7 days
Secondary outcomes:
measure: The 7-day daily sleep diary
timeFrame: 7 days
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 7 days
measure: Short Form-6D (SF-6D)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wing-Fai Yeung
role: PRINCIPAL_INVESTIGATOR
References: