nctId: NCT06351930 id: EA210473 briefTitle: CBT for Insomnia in Adolescents With ADHD overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: The University of Hong Kong class: OTHER name: Kwai Chung Hospital, Hong Kong briefSummary: 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 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% 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. conditions: Insomnia conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomised, assessor-blind, parallel group controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: CBT-I + UC group measure: Change in Insomnia Symptoms measure: Change in ADHD Symptoms (Self-report) measure: Change in Internalising and Externalising Symptoms (Parent-rated) measure: Change in depressive symptoms (Self-report) measure: Change in anxiety symptoms (Self-report) measure: Change in Sleep Diary Measure - Time in Bed (TIB) measure: Change in Sleep Diary Measure - Total Sleep Time (TST) measure: Change in Sleep Diary Measure - Sleep Onset Latency (SOL) measure: Change in Sleep Diary Measure - Wake After Sleep Onset (WASO) measure: Change in Sleep Diary Measure - Sleep Efficiency (SE) measure: Change in Objective Sleep Measures - Time in Bed (TIB) measure: Change in Objective Sleep Measures - Total Sleep Time (TST) measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL) measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO) measure: Change in Objective Sleep Measures - Sleep Efficiency (SE) measure: Change in Individual Beliefs and Attitude about Sleep measure: Change in Adolescent Sleep Hygiene measure: Change in Quality of Life sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Waiyan Vivian CHIU, Clinical Psychologist role: CONTACT lat: 22.27832 lon: 114.17469 facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Shirley X Li, PhD, DClinPsy role: CONTACT phone: 852-39177035 email: shirley.li@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False