Group Cognitive Behavioral Therapy and Acupressure for Insomnia

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03291301
Collaborator
(none)
40
2
3
5.6
20
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Other: Acupressure
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Cognitive Behavioral Therapy (CBT) and Acupressure for Insomnia: A Pilot Randomized Controlled Trial
Actual Study Start Date :
Dec 11, 2017
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBT Group

Cognitive Behavioral Therapy for Insomnia

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

Experimental: Combined Group

Cognitive Behavioral Therapy for Insomnia plus Acupressure

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

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

No Intervention: Wait-list Control Group

Outcome Measures

Primary Outcome Measures

  1. Change in Insomnia Severity Index [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 Outcome Measures

  1. Change in 7-Day Sleep Diary [Pre-treatment, 1-week post-treatment and 4-week post treatment]

    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.

  2. Change in Hospital Anxiety and Depression Scale (HADS) [Pre-treatment, 1-week post-treatment and 4-week post treatment]

    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.

  3. 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]

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

  4. Change in Multidimensional Fatigue Inventory (MFI) [Pre-treatment, 1-week post-treatment and 4-week post treatment]

    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.

  5. 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]

    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.

Other Outcome Measures

  1. Change in Credibility-Expectancy Questionnaire (CEQ) [Pre-treatment and 1-week post-treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Hong Kong Hong Kong
2 The Chinese University of Hong Kong Sha Tin Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fiona YY Ho, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03291301
Other Study ID Numbers:
  • PSY001
First Posted:
Sep 25, 2017
Last Update Posted:
Oct 24, 2018
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fiona YY Ho, Assistant Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2018