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Group Cognitive Behavioral Therapy and Acupressure for Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Acupressure
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive Behavioral Therapy, CBT-I, Acupressure, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chinese University of Hong Kong
  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

CBT Group

Combined Group

Wait-list Control Group

Arm Description

Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia plus Acupressure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.

Full Information

First Posted
September 15, 2017
Last Updated
October 23, 2018
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03291301
Brief Title
Group Cognitive Behavioral Therapy and Acupressure for Insomnia
Official Title
The Efficacy of Cognitive Behavioral Therapy (CBT) and Acupressure for Insomnia: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive Behavioral Therapy, CBT-I, Acupressure, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT Group
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for Insomnia
Arm Title
Combined Group
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for Insomnia plus Acupressure
Arm Title
Wait-list Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
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 Outcome Measure Information:
Title
Change in 7-Day Sleep Diary
Description
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
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)
Description
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
Title
Change in Multidimensional Fatigue Inventory (MFI)
Description
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
Title
Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
Description
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 Pre-specified Outcome Measures:
Title
Change in Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
Pre-treatment and 1-week post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

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Group Cognitive Behavioral Therapy and Acupressure for Insomnia

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