InsomniaNCT05133908
dCBTi for Adults With ADHD
A study testing dCBTi-ADHD in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insomnia
- What is being tested?
- dCBTi-ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Feb 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (a) Hong Kong resident,
- (b) Aged between 18-60,
- (c) Diagnosed with ADHD,
- (d) Able to read and write Chinese,
- (e) Has regular access to a smart phone and internet,
- (f) Insomnia severity index ⩾10
Who cannot join
- (a) Having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder,
- (b) Having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy),
- (c) Having night shift schedules at work,
- (d) Currently receiving psychological intervention for insomnia
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Wai Sze Chan, PhD, slashlab@hku.hk
About this study
Official title: A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.
Read the detailed description
Participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. Participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks.
Question 1:
Does dCBTi work better than the active control?
Hypothesis 1:
Improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group.
Question 2:
Does improvement in insomnia due to dCBTi lead to improvement in ADHD outcomes?
Hypothesis 2:
Improvement in ADHD outcomes would be greater for the experimental group than the active control group. The effect of dCBTi on ADHD outcomes would be mediated by improvement in insomnia.
Question 3:
Does improvement in insomnia due to dCBTi lead to improvement in mental well-being?
Hypothesis 3:
Improvement in outcomes related to mental well-being would be greater for the experimental group than the active control group. The effect of dCBTi on outcomes related to mental well-being would be mediated by improvement in insomnia.
- Conditions
- Insomnia
- Being tested
- Sleep Hygiene and Self-Monitoring Control, dCBTi-ADHD
- Keywords
- Digital intervention, Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene and Self-Monitoring ControlBehavioural
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
dCBTi-ADHDBehavioural
The dCBTi adopts a multi-module approach, consisting of 7 weekly modules including psychoeducation on sleep and ADHD, insomnia, organization strategies and distractibility reduction skills, sleep hygiene, sleep restriction and prescription, circadian-related activity scheduling, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep. A virtual coach is also included in the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.
| Study group | Role | What they receive |
|---|---|---|
| Digital Sleep Hygiene and Self-Monitoring Control | Active comparator | Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations Receives: Behavioral: Sleep Hygiene and Self-Monitoring Control |
| dCBTi-ADHD | Experimental | Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD Receives: Behavioral: dCBTi-ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insomnia Severity Index (ISI)
Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms
Measured: 13 weeks from baseline
Secondary outcomes (11)
Changes in total sleep time (TST)
Total sleep time (TST) measured by Consensus Sleep Diary. Its units is minutes. Higher TST indicates longer total sleep duration.
Measured: 13 weeks from baseline
Changes in sleep efficiency (SE)
Sleep efficiency (SE) measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep
Measured: 13 weeks from baseline
Changes in sleep onset latency (SOL)
Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia
Measured: 13 weeks from baseline
Changes in midsleep time (MST)
Midsleep time (MST) measured by Consensus Sleep Diary. Its unit is time. Earlier MST indicates earlier overall timing of sleep.
Measured: 13 weeks from baseline
Changes in fatigue
Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue
Measured: 13 weeks from baseline
Changes in depressive symptoms
Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed
Measured: 13 weeks from baseline
Changes in anxiety symptoms
Anxiety symptoms measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7). The score ranges from 0 to 21, the higher the more anxious
Measured: 13 weeks from baseline
Changes in mental wellbeing
Mental well-being measured by the Warwick Edinburgh Mental Well-being Scale (WEMWBS). The score ranges from 14 to 70, the higher the greater level of mental well-being
Measured: 13 weeks from baseline
Changes in ADHD symptoms
ADHD symptoms measured by the Adult ADHD Self-Report Scale (ASRS). The score ranges from 0 to 72, the higher the greater symptom severity
Measured: 13 weeks from baseline
Changes in functional impairment due to ADHD symptoms
Functional impairment due to ADHD symptoms measured by three questions evaluating the extent to which individuals' ADHD symptoms affect their ability to function in the domains of work/study, housekeeping, and social relationships. The questions are rated on a 4-point scale, with higher ratings indicating higher level of impairment
Measured: 13 weeks from baseline
Changes in executive skills
Executive skills measured by the Executive Skills Questionnaire-Revised (ESQ-R). The score ranges from 0 to 75, the lower the stronger executive skills
Measured: 13 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start21 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Wai Sze, The University of Hong Kong
- Investigators
- Wai Sze Chan, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133908
- Sponsor's protocol ID
- EA210505
- Status last verified
- Feb 2022
- First submitted
- 22 Nov 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05133908
- Acronym / sponsor ID
- EA210505
- Conditions
- Insomnia
- Keywords
- Digital intervention, Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Nov 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.
The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.
Detailed description
Participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. Participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks.
Question 1:
Does dCBTi work better than the active control?
Hypothesis 1:
Improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group.
Question 2:
Does improvement in insomnia due to dCBTi lead to improvement in ADHD outcomes?
Hypothesis 2:
Improvement in ADHD outcomes would be greater for the experimental group than the active control group. The effect of dCBTi on ADHD outcomes would be mediated by improvement in insomnia.
Question 3:
Does improvement in insomnia due to dCBTi lead to improvement in mental well-being?
Hypothesis 3:
Improvement in outcomes related to mental well-being would be greater for the experimental group than the active control group. The effect of dCBTi on outcomes related to mental well-being would be mediated by improvement in insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Sleep Hygiene and Self-Monitoring Control | Active comparator | Behavioral: Sleep Hygiene and Self-Monitoring ControlParticipants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations |
| dCBTi-ADHD | Experimental | Behavioral: dCBTi-ADHDParticipants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- (a) Hong Kong resident,
- (b) Aged between 18-60,
- (c) Diagnosed with ADHD,
- (d) Able to read and write Chinese,
- (e) Has regular access to a smart phone and internet,
Key exclusion criteria (4 listed)
- (a) Having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder,
- (b) Having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy),
- (c) Having night shift schedules at work,
- (d) Currently receiving psychological intervention for insomnia
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 |
|---|---|---|
| Sleep Hygiene and Self-Monitoring ControlAn app with self-monitoring function and videos and written materials about sleep hygiene will be provided. | Behavioural | Digital Sleep Hygiene and Self-Monitoring Control |
| dCBTi-ADHDThe dCBTi adopts a multi-module approach, consisting of 7 weekly modules including psychoeducation on sleep and ADHD, insomnia, organization strategies and distractibility reduction skills, sleep hygiene, sleep restriction and prescription, circadian-related activity scheduling, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep. A virtual coach is also included in the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies. | Behavioural | dCBTi-ADHD |
Primary outcome
Changes in Insomnia Severity Index (ISI)
Time frame: 13 weeks from baseline
Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms
11 secondary outcomes
Changes in total sleep time (TST)
Time frame: 13 weeks from baseline
Changes in sleep efficiency (SE)
Time frame: 13 weeks from baseline
Changes in sleep onset latency (SOL)
Time frame: 13 weeks from baseline
Changes in midsleep time (MST)
Time frame: 13 weeks from baseline
Changes in fatigue
Time frame: 13 weeks from baseline
Changes in depressive symptoms
Time frame: 13 weeks from baseline
Changes in anxiety symptoms
Time frame: 13 weeks from baseline
Changes in mental wellbeing
Time frame: 13 weeks from baseline
Changes in ADHD symptoms
Time frame: 13 weeks from baseline
Changes in functional impairment due to ADHD symptoms
Time frame: 13 weeks from baseline
Changes in executive skills
Time frame: 13 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.
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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.
Wai Sze Chan, 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 dCBTi-ADHD 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 4 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 14 Mar 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 Wai Sze Chan, PhD ((852) 3917 2295, chanwais@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity Index (ISI) (time frame: 13 weeks from baseline). 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 14 Mar 2022.