Group Cognitive Behavioral Therapy and Acupressure for Insomnia

NCT03291301 | Completed

• 1 other identifier: PSY001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in 7-Day Sleep Diary

  Pre-treatment, 1-week post-treatment and 4-week post treatment

• Change in Hospital Anxiety and Depression Scale (HADS)

  Pre-treatment, 1-week post-treatment and 4-week post treatment

• Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)

  Pre-treatment, 1-week post-treatment and 4-week post treatment

• Change in Multidimensional Fatigue Inventory (MFI)

  Pre-treatment, 1-week post-treatment and 4-week post treatment

• 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 treatment

Other Outcomes (1)

• Change in Credibility-Expectancy Questionnaire (CEQ)

  Pre-treatment and 1-week post-treatment

Study Arms (3)

CBT Group

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

Combined Group

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia plus Acupressure

Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Acupressure

Wait-list Control Group

NO INTERVENTION

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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

CBT Group; Combined Group

Acupressure OTHER

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

Combined Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Acupressure

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 25, 2017
• Study Start: December 11, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

HK (2)