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Completed

NCT Number: NCT03291301

Group Cognitive Behavioral Therapy and Acupressure for Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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

Acupressure

Other

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

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: 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 outcomes

  1. Change in 7-Day Sleep Diary

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Change in Credibility-Expectancy Questionnaire (CEQ)

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

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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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