InsomniaCBTINCT04653155
Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT
A study testing Cognitive behavioural therapy for insomnia in people with Insomnia, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive behavioural therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia
- Chinese aged 18-65 years old
- Chinese reading and writing proficiency of primary school
- Ability to give consent
- Accept randomization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Psychology, New Territories East Cluster, Hospital Authority
Hong Kong
Amy Kwok, PhD, 3919 7716, kwokpl@ha.org.hk
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Insomnia
- Being tested
- Cognitive behavioural therapy for insomnia
- Keywords
- Cognitive behaviour therapy, group treatment, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy for insomniaBehavioural
Cognitive behavioural therapy for insomnia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Insomnia Symptom Inventory at 3 months
Secondary outcomes (4)
Change in Dysfunctional Beliefs about Sleep Scale (DBAS) (Morin et al, 2007)
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.
Measured: Change from baseline Dysfunctional Beliefs about Sleep Scale at 3 months
Change in Patient Health Questionnaire 9 (PHQ-9) (Kroenke & Spitzer, 2002)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Change from baseline Work and Social Adjustment Scale at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jun 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kwok Pui Ling Amy, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653155
- Sponsor's protocol ID
- CREC 2019.126
- Acronym
- CBTI
- Status last verified
- Dec 2020
- First submitted
- 14 Aug 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04653155
- Acronym / sponsor ID
- CBTI / CREC 2019.126
- Conditions
- Insomnia
- Keywords
- Cognitive behaviour therapy, group treatment, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Behavioral: Cognitive behavioural therapy for insomniaParticipants in the treatment group will show significant improvement on insomnia symptoms after intervention compared to those in the waitlist control group. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Insomnia
- Chinese aged 18-65 years old
- Chinese reading and writing proficiency of primary school
- Ability to give consent
- Accept randomization
Key exclusion criteria (8 listed)
- substance abuse or dependence
- manic or hypomanic episode
- schizophrenia
- personality disorders
- posttraumatic stress disorder (PTSD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy for insomniaCognitive behavioural therapy for insomnia | Behavioural | Treatment arm |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy for insomnia in people with Insomnia, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Kwok, PhD (+852 39197716, kwokpl@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Symptom Inventory (ISI) (Bastien et al, 2001) (time frame: Change from baseline Insomnia Symptom Inventory at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.