Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351930
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-01
Brief Title:
CBT for Insomnia in Adolescents With ADHD
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Efficacy of Cognitive Behaviour Therapy for Insomnia CBT-I in Adolescents With Attention Deficit Hyperactivity Disorder ADHD A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insomnia and attention deficit hyperactivity disorder ADHD are highly comorbid conditions with an intricate bidirectional relationship In particular insomnia and ADHD often co-occur with 229-346 of adolescents with insomnia having clinically significant ADHD and 22-335 of adolescents with ADHD experiencing comorbid insomnia symptoms Insomnia is not only associated with increased ADHD severity but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia Nonetheless when treating adolescent insomnia especially those with ADHD there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence a challenging developmental stage To date there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia CBT-I in adolescents with comorbid ADHD and insomnia To address the limitations in the existing literature this study aims to conduct a randomised controlled trial RCT to examine the effects of CBT-I relative to a usual care UC condition in adolescents with ADHD on improving sleep and ADHD symptoms and other clinical and daytime symptoms as well as overall functional improvement
Detailed Description:
An assessor-blind parallel-group randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia Eligible participants will be randomised to either CBT-I UC or UC condition Assessments will be conducted at baseline T1 one-week post-treatment T4 and post-treatment 3-month T5 In addition participants in both conditions will complete the Insomnia Severity Index ISI at T2 week 2 and T3 week 4 during the intervention A random sample of 15 participants per group will be assessed for sleep objectively using actigraphy for 7 consecutive days at baseline T1 and one-week post-treatment T4 Participants in the control group will be offered CBT-I after post-treatment 3-month follow-up During the study period all the participants will continue their regular clinical follow-ups with their attending psychiatrist for the prescription of psychotropic medications if needed for managing their ADHD and mental health condition Prescription of any psychotropic medications of each participant during the trial will be reviewed and documented at baseline and at each follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None