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Group Cognitive Behavioral Therapy and Acupressure for Insomnia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03291301
Enrollment
40
Registered
2017-09-25
Start date
2017-12-11
Completion date
2018-05-31
Last updated
2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia, Cognitive Behavioral Therapy, CBT-I, Acupressure, Traditional Chinese Medicine

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.

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Insomnia Severity IndexPre-treatment, 1-week post-treatment and 4-week post treatmentA 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

MeasureTime frameDescription
Change in 7-Day Sleep DiaryPre-treatment, 1-week post-treatment and 4-week post treatmentThe 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)Pre-treatment, 1-week post-treatment and 4-week post treatmentA 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 Multidimensional Fatigue Inventory (MFI)Pre-treatment, 1-week post-treatment and 4-week post treatmentA 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)Pre-treatment, 1-week post-treatment and 4-week post treatmentA 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.
Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)Pre-treatment, 1-week post-treatment and 4-week post treatmentA 16-item self-report measure designed to evaluate sleep related cognitions (e.g., faulty beliefs and appraisals, unrealistic expectations, perceptual and attention bias).

Other

MeasureTime frameDescription
Change in Credibility-Expectancy Questionnaire (CEQ)Pre-treatment and 1-week post-treatmentThe 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026