Group Cognitive Behavioral Therapy and Acupressure for Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291301
• Other study ID #: PSY001
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Credibility-Expectancy Questionnaire (CEQ)	The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.	Pre-treatment and 1-week post-treatment
Primary	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.	Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary	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.	Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary	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.	Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary	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).	Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary	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.	Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary	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.	Pre-treatment, 1-week post-treatment and 4-week post treatment