InsomniaNCT03736694

Low-intensity Cognitive-behavioural Therapy for Insomnia

A study testing Cognitive behavioural therapy for insomnia and Sleep hygiene education in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Insomnia
What is being tested?: Cognitive behavioural therapy for insomnia and Sleep hygiene education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteHong Kong
Study dates: 1 Sep 2018to 31 Jul 2019
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Hong Kong residents
Aged 16 or above
Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
Score at least 10 points in Insomnia Severity Index
Able to read and understand Cantonese
Have Internet access

Who cannot join

Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
Currently receiving CBTI or SHE
Work on irregular rotational shift

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The University of Hong Kong
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong

A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. Therefore, it is significant to conduct this study. A total of 210 participants aged > 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.

Conditions: Insomnia
Being tested: Cognitive behavioural therapy for insomnia, Sleep hygiene education
Keywords: Insomnia, Cognitive behavioural therapy for insomnia, Sleep hygiene education
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
CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, \& Daley, 2003). It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, \& Denberg, 2016). CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, \& Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, \& Brown, 2012). Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, \& Meijer, 2015).
Sleep hygiene educationBehavioural
SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, \& Daley, 2003).

Study groups in NCT03736694
Study group	Role	What they receive
CBTI Workshop	Experimental	The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, \& Swanson, et al, 2014; Morin, Savard, Ouellet, \& Daley, 2003). One workshop has the capacity of 30 participants. Receives: Behavioral: Cognitive behavioural therapy for insomnia
Self-Help CBTI	Experimental	The second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1. Receives: Behavioral: Cognitive behavioural therapy for insomnia
SHE Workshop	Active comparator	The control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants. Receives: Behavioral: Sleep hygiene education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insomnia severity
To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy \& Swanson, et al, 2014; Wong, Zhang \& Li, et al, 2017).
Measured: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

Secondary outcomes (2)

Change in Symptoms of Mood disorders
To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
Measured: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Change in Quality of life
To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
Measured: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201831 Jul 2019

First posted9 Nov 2018
Study start1 Sep 2018
Primary completion30 Jun 2019
Study completion31 Jul 2019

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.
More trials run by The University of Hong KongThe sponsor's other registered studies.
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: A prospective randomized controlled trial (RCT) will be performed to compare the effectiveness of the 3 types of therapies. After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator. The first intervention group (Group 1) will attend one half-day cognitive behavioural therapy for insomnia (CBTI) workshop in the community setting. The second intervention group (Group 2) will receive self-help CBTI. The control group (Group 3) will receive sleep hygiene education (SHE).
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03736694
Sponsor's protocol ID: UW 18-396
Status last verified: Mar 2020
First submitted: 7 Nov 2018
Last updated: 25 Mar 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong
ClinicalTrials.gov ID: NCT03736694
Acronym / sponsor ID: UW 18-396
Conditions: Insomnia
Keywords: Insomnia, Cognitive behavioural therapy for insomnia, Sleep hygiene education
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: 1 Sep 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 9 Nov 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: A prospective randomized controlled trial (RCT) will be performed to compare the effectiveness of the 3 types of therapies. After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator. The first intervention group (Group 1) will attend one half-day cognitive behavioural therapy for insomnia (CBTI) workshop in the community setting. The second intervention group (Group 2) will receive self-help CBTI. The control group (Group 3) will receive sleep hygiene education (SHE).

Arm	Type	Receives
CBTI Workshop	Experimental	Behavioral: Cognitive behavioural therapy for insomniaThe first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, \& Swanson, et al, 2014; Morin, Savard, Ouellet, \& Daley, 2003). One workshop has the capacity of 30 participants.
Self-Help CBTI	Experimental	Behavioral: Cognitive behavioural therapy for insomniaThe second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1.
SHE Workshop	Active comparator	Behavioral: Sleep hygiene educationThe control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Hong Kong residents
Aged 16 or above
Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
Score at least 10 points in Insomnia Severity Index
Able to read and understand Cantonese

Key exclusion criteria (3 listed)

Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
Currently receiving CBTI or SHE
Work on irregular rotational shift

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 insomniaCBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, \& Daley, 2003). It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, \& Denberg, 2016). CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, \& Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, \& Brown, 2012). Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, \& Meijer, 2015).	Behavioural	CBTI Workshop, Self-Help CBTI
Sleep hygiene educationSHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, \& Daley, 2003).	Behavioural	SHE Workshop

Primary outcome

Change in Insomnia severity
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy \& Swanson, et al, 2014; Wong, Zhang \& Li, et al, 2017).

2 secondary outcomes

Change in Symptoms of Mood disorders
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Change in Quality of life
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.

Related trials for Insomnia

Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 and Sleep hygiene education in people with Insomnia, run by The University of 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insomnia severity (time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03736694.

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 25 Mar 2020.