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CompletedNCT03291301Updated Oct 24, 2018

Group Cognitive Behavioral Therapy and Acupressure for Insomnia

An interventional study of Cognitive Behavioral Therapy for Insomnia and Acupressure in Insomnia, sponsored by Chinese University of Hong Kong. Completed at 2 sites in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia

Keywords

  • Insomnia
  • Cognitive Behavioral Therapy
  • CBT-I
  • Acupressure
  • Traditional Chinese Medicine
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 ;
  2. Receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure treatment for insomnia in the past 6 months;
  3. Pregnancy; and
  4. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    CBT Group

    Cognitive Behavioral Therapy for Insomnia

    Behavioral: Cognitive Behavioral Therapy for Insomnia

  • Experimental
    Combined Group

    Cognitive Behavioral Therapy for Insomnia plus Acupressure

    Behavioral: Cognitive Behavioral Therapy for Insomnia · Other: Acupressure

  • No intervention
    Wait-list Control Group

Interventions

  • BehavioralCognitive Behavioral Therapy for Insomnia

    Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.

  • OtherAcupressure

    Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine

05

What researchers measure

Primary outcomes

  1. Change in Insomnia Severity Index

    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.

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

Secondary outcomes

  1. Change in 7-Day Sleep Diary

    The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min); sleep efficiency (SE; calculated as TST/TIB \* 100%), etc.

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

  2. Change in Hospital Anxiety and Depression Scale (HADS)

    A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purpose and not meant to be a diagnostic tool.

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

  3. Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)

    A 16-item self-report measure designed to evaluate sleep related cognitions (e.g., faulty beliefs and appraisals, unrealistic expectations, perceptual and attention bias).

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

  4. Change in Multidimensional Fatigue Inventory (MFI)

    A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.

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

  5. Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)

    A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.

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

Other outcomes

  1. Change in Credibility-Expectancy Questionnaire (CEQ)

    The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.

    Time frame: Pre-treatment and 1-week post-treatment

06

Study locations

2 sites
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong
  • The Chinese University of Hong Kong
    Sha Tin, Hong Kong
07

Registry details

Key details

Study ID
NCT03291301
Lead sponsor
Chinese University of Hong Kong
Responsible party
Fiona YY Ho (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 25, 2017
Start date
Dec 11, 2017
Primary completion
Apr 30, 2018
Completion
May 31, 2018
Last update
Oct 24, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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