Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-24 @ 11:06 PM
NCT ID:
NCT07209969
Brief Summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity, affecting individuals across the lifespan. While the core symptoms of ADHD are well-documented, emerging research has shed light on the prevalence of comorbid sleep disturbances, particularly insomnia, among adolescents with ADHD. The co-occurrence of ADHD and insomnia can exacerbate cognitive and emotional difficulties, impacting various aspects of daily functioning. Cognitive-Behavioral Therapy for Insomnia (CBT-I) has proven effective in addressing sleep-related difficulties in various populations. However, there is a paucity of research specifically examining the efficacy of CBT-I in adolescents with ADHD. To date, there was only one pilot single-arm sleep intervention study conducted in adolescents with ADHD (Becker et al., 2021) and one randomized controlled trial of sleep intervention in adolescents with ADHD that is still undergoing data collection (Keuppens et al., 2023). Given the lack of research on the intervention for insomnia in the context of ADHD, this study aimed to evaluate the efficacy of CBT-I on adolescents with ADHD in insomnia symptoms, sleep related cognitions and practices, ADHD severity, emotion regulation ability, and depressive and anxiety symptoms.
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 group (intervention) or treatment-as-usual (TAU) control group. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. During the study period, all the participants will continue their regular clinical follow-ups with their attending psychiatrist for the prescription of psychotropic medication(s), 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:
NCT07209969
Study Brief:
Protocol Section:
NCT07209969