Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT (CBTI)

December 3, 2020 updated by: Kwok Pui Ling Amy, Hospital Authority, Hong Kong

Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a Randomized Controlled Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Insomnia is characterized by difficulty in initiating sleep, difficulty in maintaining sleep, early morning awakening and non-restorative sleep, which should be relatively frequent (>/= 3 times/ week), persistent (>/= 2-4 weeks) and severe enough to affect daytime functioning. It is among the most common mental disorders. Epidemiological surveys in Western countries found a high prevalence of insomnia syndrome (9.2-13%) and insomnia symptoms (11.4% to 38%). In Hong Kong, a prevalence of 11.9% was reported for community adults. Given such high prevalence, insomnia is evidently one major health concern across diverse communities, including Hong Kong. Furthermore, the disorder runs a chronic and debilitating course if untreated.

Interrelationships between insomnia and mental health are now well established in the epidemiological literature, with insomnia shown to be frequently comorbid with mental health concerns, such as depression or anxiety and risk of suicide. Insomnia symptoms have repeatedly been shown to increase the risk of subsequent depression. Also, it is shown that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with depression and comorbid insomnia in terms of alleviating both depression and insomnia. It is clear that insomnia is not only a disorder of high personal suffering, but is also associated with high and recurring societal costs. These facts strongly argue for the need of effective treatments to relieve personal suffering, caring burdens, and societal economic costs.

Fortunately, there are effective treatments available for insomnia, particularly cognitive-behavioural therapy (CBT). In a number of meta-analysis of insomnia treatments, CBT is effective and consistently performs better than placebo and other control conditions in improving nighttime insomnia symptoms, including sleep latency, total sleep time, wake after sleep onset, and insomnia symptoms. CBT for insomnia (CBTi) packages include stimulus control, relaxation, sleep restriction and their combination meet APA criteria for empirically validated treatment for insomnia based on the strength of results from a number of empirical studies.

Unfortunately, while effective psychological treatments exist, there is only limited manpower to provide the intervention. Western studies showed that 15-25% of children and adults were suffering from mental health disorders, but only 20-30% of them had access to treatment. Locally in Hong Kong, we are facing an almost identical situation. About 15% of children and adults suffered from mental health disorders, but again only 15-30% of them had access to mental health services. Obviously, a shortage of mental health professionals such as psychiatrists or clinical psychologists is a worldwide phenomenon. In Hong Kong, our situation regarding the availability of clinical psychologists (CPs) in providing psychological treatment is even worse. We have a ratio of approximately 1 CP to 18,000 in the Hong Kong population, far below the ratio of 1 in 3,500 in the USA.

Most governments, including those of richer countries like USA, will admit that they will never have the resources to increase the number of mental health professionals like psychiatrists and CPs to meet the societal demand. Instead, a more viable solution is to look for greater cost-efficiency in delivering services. Recent meta-analyses find the effectiveness of group psychological treatment (mostly CBT) for insomnia as largely comparable to that of traditional one on one therapy. Group therapy is thus advocated as a less-intensive, cost-effective way to offer evidence-based treatment.

Based on Morin, we developed a treatment protocol for CBTi, incorporating both education and individualized feedback. The protocol implements all of the key procedures in one-on-one CBTi such as sleep restriction, stimulus control, managing dysfunctional beliefs about sleep, behavioural experiments, increasing energizing behaviours, all of which target the maintaining factors of insomnia. Patients would be assigned a therapist to follow up on them via either brief (5-10 minutes) telephone calls. Compared to traditional face to face CBTi, the protocol requires 32% of the therapist's time of the latter, i.e., a 68% drop in the therapist's time.

There is a paucity of study in the effectiveness of cognitive behaviour therapy for insomnia in Hong Kong Chinese, let alone CBTi in group. This proposal aims at developing a CBTi protocol for treatment of insomnia in Hong Kong to increase the access of evidence-based treatment to local Chinese insomnia adults. This involves protocol development, test-run and a randomized controlled trial (RCT) with a waitlist control group and a short-term follow-up of three months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Clinical Psychology, New Territories East Cluster, Hospital Authority
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment arm
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
Cognitive behavioural therapy for insomnia
No Intervention: Waitlist control
Participants in the waitlist control group will show little improvement on insomnia symptoms after the treatment period of the treatment group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Insomnia Symptom Inventory (ISI) (Bastien et al, 2001)
Time Frame: Change from baseline Insomnia Symptom Inventory at 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Dysfunctional Beliefs about Sleep Scale (DBAS) (Morin et al, 2007)
Time Frame: Change from baseline Dysfunctional Beliefs about Sleep Scale at 3 months
A self-report questionnaire for evaluation of cognition, behaviours and attitudes related to insomnia. All items are assessed on a 5-point scale (0-4). Its total score ranged between 0 to 112, with higher score representing more dysfunctional beliefs about sleep.
Change from baseline Dysfunctional Beliefs about Sleep Scale at 3 months
Change in Patient Health Questionnaire 9 (PHQ-9) (Kroenke & Spitzer, 2002)
Time Frame: Change from baseline Patient Health Questionnaire 9 (PHQ-9) at 3 months
A 9-item self-report questionnaires for evaluation of depression. All items are assessed on a 4-point scale (0-3). Its total score ranged between 0 to 27, with higher score representing more severe depressive symptoms.
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)
Time Frame: Change from baseline Generalized Anxiety Disorder-7 item (GAD-7) Questionnaire at 3 months
A 7-item self-report questionnaires for evaluation of general anxiety. All items are assessed on a 4-point scale (0-3), with its total score ranging between 0 to 21. Higher score representing increased anxiety symptoms.
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)
Time Frame: Change from baseline Work and Social Adjustment Scale at 3 months
A 5-item simple self-report measure of impairment in functioning. All items are assessed on a 9-point scale (0-8), with its total score ranging between 0 to 40. Higher score representing greater impairment in functioning
Change from baseline Work and Social Adjustment Scale at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Authority, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CREC 2019.126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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