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Clinical Trials/NCT03291301
NCT03291301
Completed
Not Applicable

The Efficacy of Cognitive Behavioral Therapy (CBT) and Acupressure for Insomnia: A Pilot Randomized Controlled Trial

Chinese University of Hong Kong1 site in 1 country40 target enrollmentDecember 11, 2017
ConditionsInsomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Chinese University of Hong Kong
Enrollment
40
Locations
1
Primary Endpoint
Change in Insomnia Severity Index
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation. CBT-I is widely used in western countries but it fails to address patient preference among Chinese adults with insomnia, as demonstrated in a previous study examining the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of psychological interventions for insomnia, integrative medicine with a combination of CBT-I and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of their combination.

Registry
clinicaltrials.gov
Start Date
December 11, 2017
End Date
May 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fiona YY Ho

Assistant Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Hong Kong residents who are able to communicate in Cantonese;
  • Aged ≥ 18 years;
  • A current clinical DSM-5 diagnosis of insomnia disorder according to the Sleep Condition Indicator (SCI) ≥ 21;
  • Insomnia Severity Index (ISI) score ≥ 8; and
  • Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria

  • Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 ;
  • Receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure treatment for insomnia in the past 6 months;
  • Pregnancy; and
  • Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment.

Outcomes

Primary Outcomes

Change in Insomnia Severity Index

Time Frame: Pre-treatment, 1-week post-treatment and 4-week post treatment

A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.

Secondary Outcomes

  • Change in Hospital Anxiety and Depression Scale (HADS)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
  • Change in Multidimensional Fatigue Inventory (MFI)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
  • Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)(Pre-treatment, 1-week post-treatment and 4-week post treatment)
  • Change in 7-Day Sleep Diary(Pre-treatment, 1-week post-treatment and 4-week post treatment)
  • Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)(Pre-treatment, 1-week post-treatment and 4-week post treatment)

Study Sites (1)

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