Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT

NCT04653155 | Unknown

• 1 other identifier: CREC 2019.126
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Insomnia is a common mental problem, where people experienced difficulty falling asleep, problem maintaining asleep and early morning awakening. It is highly prevalent world-wide and in Hong Kong, causing significant suffering and distress. While evidence based intervention exists, e.g. cognitive-behavioural therapy (CBT), there will not enough therapists to meet treatment demand. A more efficient delivery of treatment, e.g. internet based therapy is called for that can delivery treatment more cost efficiently by requiring lesser therapist time. Objective: This study aims at evaluating the effectiveness of CBTi (Gp) on treating Chinese insomniac adults in Hong Kong. There has been criticism that most clinical trials have been conducted with Caucasians in Western countries and little has been done with ethnic minorities, including Asians in these countries, not to mention Asians in Asian countries, e.g., Chinese in Hong Kong. Design: A two-arm parallel-group randomised controlled trial, comparing the treatment and waitlist group Method: A CBTi protocol would be developed. Approximately 60 Chinese adults with insomnia will be recruited in Hong Kong and randomised into one of the two groups (treatment vs. waitlist). The treatment last for 6 weeks, plus a 3-month follow-up period. The primary outcome measure will be Insomnia Severity Index (ISI).

Conditions

Insomnia

Keywords

Cognitive behaviour therapy, group treatment, insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Symptom Inventory (ISI) (Bastien et al, 2001)

  A 7-item self-report questionnaire assessing the nature, severity and the impact of insomnia. Insomnia Symptom Inventory is the primary outcome measure. All items are assessed on a 5-point scale (0-4), with its total score ranging between 0 to 28. Higher score representing worse insomnia symptoms.

  Change from baseline Insomnia Symptom Inventory at 3 months

Secondary Outcomes (4)

• Change in Dysfunctional Beliefs about Sleep Scale (DBAS) (Morin et al, 2007)

  Change from baseline Dysfunctional Beliefs about Sleep Scale at 3 months

• Change in Patient Health Questionnaire 9 (PHQ-9) (Kroenke & Spitzer, 2002)

  Change from baseline Patient Health Questionnaire 9 (PHQ-9) at 3 months

• Change in Generalized Anxiety Disorder-7 item (GAD-7) Questionnaire (Spitzer et al, 2006)

  Change from baseline Generalized Anxiety Disorder-7 item (GAD-7) Questionnaire at 3 months

• Change in Work and Social Adjustment Scale (WSAS) (Mundt et al, 2002)

  Change from baseline Work and Social Adjustment Scale at 3 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

Participants in the treatment group will show significant improvement on insomnia symptoms after intervention compared to those in the waitlist control group.

Behavioral: Cognitive behavioural therapy for insomnia

Waitlist control

NO INTERVENTION

Participants in the waitlist control group will show little improvement on insomnia symptoms after the treatment period of the treatment group.

Interventions

Cognitive behavioural therapy for insomnia BEHAVIORAL

Cognitive behavioural therapy for insomnia

Treatment arm

Eligibility Criteria

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

You may qualify if:

• Insomnia
• Chinese aged 18-65 years old
• Chinese reading and writing proficiency of primary school
• Ability to give consent
• Accept randomization

You may not qualify if:

• substance abuse or dependence
• manic or hypomanic episode
• schizophrenia
• personality disorders
• posttraumatic stress disorder (PTSD)
• mental retardation
• organic mental disorder
• Suicidal risk or a suicidal attempt in the past three months

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Department of Clinical Psychology, New Territories East Cluster, Hospital Authority

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

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

Central Study Contacts

Amy Kwok, PhD

CONTACT

+852 39197716; kwokpl@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: December 4, 2020
• Study Start: June 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)