InsomniaNCT05551806
Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy in Reducing Insomnia Among Adult Population
A study testing Internet-based self-help cognitive behavioural therapy in people with Insomnia, run by Education University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet-based self-help cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jul 2022to 31 Dec 2023
- 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
- Hong Kong residents
- Age ≥18 years
- Insomnia Severity Index score > 7 and < 22
- Being able to read Chinese
- Have a computer, tablet and/or smartphone device with Internet access
- have a regular email address
- Willing to give informed consent and comply with the trial protocol
Who cannot join
- Receiving psychological treatment at least once per month
- Currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, and sleeping pills regularly
- Carrying a diagnosis of psychosis or schizophrenia
- Participating in any other academic studies or clinical trials related to insomnia
- Having current suicidal plans or acts or having had suicidal plans or acts within the past 12 months
- Shift workers
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Baptist Oi Kwan Social Service
Hong Kong, 999077
The Education University of Hong Kong
Hong Kong, 999077
About this study
Official title: Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy (CBT-I) in Reducing Insomnia Symptoms Among the Adult Population: A Randomized Controlled Trial
This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. In particular, this study compares the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
Read the detailed description
Although the Internet self-help CRT-I program have shown promising effect on dealing with insomnia symptoms, the effectiveness of internet self-help CBT-I in adults with sub-clinical insomnia symptoms in Hong Kong is under-studied. Therefore, the present study aimed to compare the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population. We hypothesized that (1) participants who received CBT-I treatment would have improved insomnia symptoms after the intervention as compared with the wait-list controls; (2) participants from CBT-I would have better sleep hygiene, and less dysfunctional beliefs about sleep and pre-sleep arousal after the intervention as compared with the wait-list controls; (3) participants from CBT-I would have improved mental health, daytime functioning, quality of life, and general well-being after treatment, as compared with the wait-list controls.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
- Conditions
- Insomnia
- Being tested
- Internet-based self-help cognitive behavioural therapy
- Keywords
- Cognitive Behavioural Therapy
- 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.
Internet-based self-help cognitive behavioural therapyBehavioural
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I group | Experimental | Participants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment 4 weeks after the post-intervention assessment. They will be invited to participate in an interview after completing the post-intervention assessment. Receives: Behavioral: Internet-based self-help cognitive behavioural therapy |
| Waitlist control group | No intervention | Participants in the waitlist control group will wait for 6 weeks without the CBT-I intervention and then complete the post-intervention assessment; while waiting for 4 more weeks and then completing the follow-up assessment. The waitlist control participants will start CBT-I (equivalent to that of the CBT-I group) immediately after completing the follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
The ISI assesses the change in a 5-point Likert scale, ranging from 1 (none/ very dissatisfied/ not at all noticeable, worried \& interfering) to 5 (very severe/ very satisfied/ very much noticeable, worried \& interfering).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary outcomes (15)
Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment
The PSQI assesses the change in a 4-point Likert scale, ranging from 1 (not during the past month/ very good) to 4 (three or more times a week/ very poor).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment
The 7-day consensus sleep diary will calculate the change of participants' sleep parameters from the diary data.
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Cognitive and Somatic Manifestations of Arousal on the Pre-sleep Arousal Scale (PSAS) at Post-Intervention Assessment and Follow-up Assessment
The PSAS assesses the change in a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment
The SHPS assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (always).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Sleep Related Cognition on the Dysfunctional Beliefs and Attitudes about Sleep (DBAS) at Post-Intervention Assessment and Follow-up Assessment
The DBAS assesses the change in a 10-point Likert scale, ranging from 0 (strongly disagree) to 10 (strongly agree).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Psychological Wellbeing on the World Health Organisation-Five Well-Being Index (WHO-5) at Post-Intervention Assessment and Follow-up Assessment
The WHO-5 assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (all of the time).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Psychological Distress on the Short Form of the Depression, Anxiety, and Stress Scale (DASS-21) at Post-Intervention Assessment and Follow-up Assessment
The DASS-21 assesses the change in a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Quality of Life on the Twelve-Item Short-Form (SF-12) Health Survey at Post-Intervention Assessment and Follow-up Assessment
The SF-12 assesses the change in a combination of 5-point and 3-point Likert scale, ranging respectively from 1 (poor/ never) to 5 (excellent/ very much), and 1 (never) to 3 (very much).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Functional Impairment of Insomnia on the Work and Social Adjustment Scale (WSAS) at Post-Intervention Assessment and Follow-up Assessment
The WSAS assesses the change in a 9-point Likert scale, ranging from 1 (not at all) to 9 (very severely).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Cognitive Failure on the Measure of Insight into Cognition-Self Report (MIC-SR) at Post-Intervention Assessment and Follow-up Assessment
The MIC-SR assesses the change in a 4-point Likert scale, ranging from 1 (never) to 4 (almost daily).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment
The CTRS assesses the change in a 6-point Likert scale, ranging from 1 (not at all confident) to 6 (very confident).
Measured: Before intervention, Immediately after intervention, and 4 weeks after intervention
Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment
The ITAS assesses the insomnia treatment acceptability in a 10-point Likert scale, ranging from 1 (not at all acceptable) to 10 (very acceptable).
Measured: Immediately after Post-Intervention Assessment
Treatment Adherence at the Interview after Post-Intervention Assessment
Participants report the number of sessions they had read, how long they had spent on the CBT program, and how far they had followed the instructions.
Measured: Immediately after Post-Intervention Assessment
Treatment Satisfaction at the Interview after Post-Intervention Assessment
Participants report on whether they like, found it useful, and improvement of the intervention in a 10-point Likert scale, ranging from 0 (not at all suitable) to 10 (very suitable).
Measured: Immediately after Post-Intervention Assessment
Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment
Participants report on how suitable, how convenient, how much they liked, and how worried they were about their privacy in a 10-point Likert scale, ranging from 0 (not at all suitable) to 10 (very suitable).
Measured: Immediately after Post-Intervention Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Baptist Oi Kwan Social Service
- Responsible party
- Principal investigator, CHAN Ka Shing Kevin, Education University of Hong Kong
- Investigators
- Kevin, Ka Shing CHAN, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551806
- Sponsor's protocol ID
- 2021-2022-0340
- Status last verified
- Feb 2024
- First submitted
- 1 Sep 2022
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy (CBT-I) in Reducing Insomnia Symptoms Among the Adult Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05551806
- Acronym / sponsor ID
- 2021-2022-0340
- Conditions
- Insomnia
- Keywords
- Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- Baptist Oi Kwan Social Service
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2022 (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.
This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. In particular, this study compares the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
Detailed description
Although the Internet self-help CRT-I program have shown promising effect on dealing with insomnia symptoms, the effectiveness of internet self-help CBT-I in adults with sub-clinical insomnia symptoms in Hong Kong is under-studied. Therefore, the present study aimed to compare the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population. We hypothesized that (1) participants who received CBT-I treatment would have improved insomnia symptoms after the intervention as compared with the wait-list controls; (2) participants from CBT-I would have better sleep hygiene, and less dysfunctional beliefs about sleep and pre-sleep arousal after the intervention as compared with the wait-list controls; (3) participants from CBT-I would have improved mental health, daytime functioning, quality of life, and general well-being after treatment, as compared with the wait-list controls.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I group | Experimental | Behavioral: Internet-based self-help cognitive behavioural therapyParticipants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment 4 weeks after the post-intervention assessment. They will be invited to participate in an interview after completing the post-intervention assessment. |
| Waitlist control group | No intervention | –Participants in the waitlist control group will wait for 6 weeks without the CBT-I intervention and then complete the post-intervention assessment; while waiting for 4 more weeks and then completing the follow-up assessment. The waitlist control participants will start CBT-I (equivalent to that of the CBT-I group) immediately after completing the follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hong Kong residents
- Age ≥18 years
- Insomnia Severity Index score > 7 and < 22
- Being able to read Chinese
- Have a computer, tablet and/or smartphone device with Internet access
Key exclusion criteria (6 listed)
- Receiving psychological treatment at least once per month
- Currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, and sleeping pills regularly
- Carrying a diagnosis of psychosis or schizophrenia
- Participating in any other academic studies or clinical trials related to insomnia
- Having current suicidal plans or acts or having had suicidal plans or acts within the past 12 months
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 |
|---|---|---|
| Internet-based self-help cognitive behavioural therapyThe online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. | Behavioural | CBT-I group |
Primary outcome
Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
The ISI assesses the change in a 5-point Likert scale, ranging from 1 (none/ very dissatisfied/ not at all noticeable, worried \& interfering) to 5 (very severe/ very satisfied/ very much noticeable, worried \& interfering).
15 secondary outcomes
Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Cognitive and Somatic Manifestations of Arousal on the Pre-sleep Arousal Scale (PSAS) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Sleep Related Cognition on the Dysfunctional Beliefs and Attitudes about Sleep (DBAS) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Psychological Wellbeing on the World Health Organisation-Five Well-Being Index (WHO-5) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Psychological Distress on the Short Form of the Depression, Anxiety, and Stress Scale (DASS-21) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Quality of Life on the Twelve-Item Short-Form (SF-12) Health Survey at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Functional Impairment of Insomnia on the Work and Social Adjustment Scale (WSAS) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Cognitive Failure on the Measure of Insight into Cognition-Self Report (MIC-SR) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment
Time frame: Immediately after Post-Intervention Assessment
Treatment Adherence at the Interview after Post-Intervention Assessment
Time frame: Immediately after Post-Intervention Assessment
Treatment Satisfaction at the Interview after Post-Intervention Assessment
Time frame: Immediately after Post-Intervention Assessment
Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment
Time frame: Immediately after Post-Intervention Assessment
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 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Kevin, Ka Shing CHAN principal investigator
The Education University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based self-help cognitive behavioural therapy in people with Insomnia, run by Education University of Hong Kong at 2 sites 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 7 inclusion and 6 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment (time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention). 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 28 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.