Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-02-21
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CBT for Insomnia in Adolescents With ADHD
NCT06351930
dCBTi With and Without Coaching Support
NCT05136638
Low-intensity Cognitive-behavioural Therapy for Insomnia
NCT03736694
Better Sleep in Psychiatric Care - ADHD Pilot Study
NCT03852966
Effects of Group-based and Digitally Delivered CBT-I in Youth
NCT05270369
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Digital Sleep Hygiene and Self-Monitoring Control
Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
Sleep Hygiene and Self-Monitoring Control
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
dCBTi-ADHD
Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD
dCBTi-ADHD
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep Hygiene and Self-Monitoring Control
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
dCBTi-ADHD
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (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
Exclusion Criteria
* (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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Chan Wai Sze
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wai Sze Chan, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Hong Kong
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EA210505
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.