InsomniaNCT05011929
Comparison of the Effects of Support and Non-support Online CBT-I
A study testing Cognitive behavioral therapy in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive behavioral therapy
- 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
- 10 Dec 2019to 1 Dec 2022
- 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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chinese aged 12-24 years old;
- Informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Having a DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
Who cannot join
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
- Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
Show all 10Show fewer
- Initiation of or change in antidepressant medication within past 2 months;
- Having been or is currently receiving any structured psychotherapy;
- With hearing or speech deficit;
- Night shift worker.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley Xin Li, PhD, DClinPsy, +852 3917-7035, shirley.li@hku.hk
About this study
Official title: Comparison of the Effects of Support and Non-support Online Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.
- Conditions
- Insomnia
- Being tested
- Cognitive behavioral 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.
Cognitive behavioral therapyBehavioural
refer to the arm description
| Study group | Role | What they receive |
|---|---|---|
| online CBT-I with support (individualized feedback and reminders) | Experimental | The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week. Receives: Behavioral: Cognitive behavioral therapy |
| online CBT-I without support | Active comparator | same as the experimental arm but without reminders and individualized feedback Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of insomnia symptoms
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Secondary outcomes (14)
Change of sleep quality
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (total time in bed)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total time in bed (minutes)
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (total sleep time)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (minutes)
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (sleep efficiency)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (%)
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (sleep onset latency)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (minutes)
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (wake after sleep onset)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (minutes).
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of daytime sleepiness
Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of daytime fatigue
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of quality of life
KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy \& parents (possibly scored 7 to 35), peers \& social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of suicidal ideation
Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of self-report mood symptoms
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of dysfunctional beliefs and attitudes about sleep
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep hygiene and practice
Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of pre-sleep arousal
Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Dec 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (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.
- 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 randomised, assessor-blind, parallel group controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Shirley Xin Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011929
- Sponsor's protocol ID
- EA
- Status last verified
- Feb 2022
- First submitted
- 24 Apr 2021
- Last updated
- 15 Feb 2022
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Support and Non-support Online Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05011929
- Acronym / sponsor ID
- EA
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Aug 2021 (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.
Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, assessor-blind, parallel group controlled trial
| Arm | Type | Receives |
|---|---|---|
| online CBT-I with support (individualized feedback and reminders) | Experimental | Behavioral: Cognitive behavioral therapyThe mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week. |
| online CBT-I without support | Active comparator | Behavioral: Cognitive behavioral therapysame as the experimental arm but without reminders and individualized feedback |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Chinese aged 12-24 years old;
- Informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Having a DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
Key exclusion criteria (10 listed)
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
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 behavioral therapyrefer to the arm description | Behavioural | online CBT-I with support (individualized feedback and reminders), online CBT-I without support |
Primary outcome
Change of insomnia symptoms
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
14 secondary outcomes
Change of sleep quality
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (total time in bed)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (total sleep time)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (sleep efficiency)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (sleep onset latency)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep diary measure (wake after sleep onset)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of daytime sleepiness
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of daytime fatigue
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of quality of life
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of suicidal ideation
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of self-report mood symptoms
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of dysfunctional beliefs and attitudes about sleep
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of sleep hygiene and practice
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Change of pre-sleep arousal
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- 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.
Shirley Xin Li, PhD principal investigator
The University of Hong Kong
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 behavioral therapy 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 4 inclusion and 10 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 15 Feb 2022. 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 Shirley Xin Li, PhD (852 39177035, shirley.li@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of insomnia symptoms (time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups). 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 15 Feb 2022.