Clinical trial NCT03291301: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cognitive Behavioral Therapy
CBT-I
Acupressure
Traditional Chinese Medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
Secondary outcomes:
measure: Change in 7-Day Sleep Diary
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
measure: Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
measure: Change in Multidimensional Fatigue Inventory (MFI)
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
measure: Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
timeFrame: Pre-treatment, 1-week post-treatment and 4-week post treatment
Other outcomes:
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Pre-treatment and 1-week post-treatment
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: