Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by persistent inattention, hyperactivity, and impulsivity. In adolescents and young people, ADHD is commonly accompanied by insomnia and circadian delay. These co-occurring sleep and circadian disturbances may negatively affect daytime functioning and overall clinical outcomes. Although cognitive behavioural therapy for insomnia (CBT-I) is considered the first-line treatment for insomnia, and bright light therapy may help address circadian issues, their efficacy in adolescents with ADHD and comorbid insomnia and eveningness remains unexplored. This study aims to evaluate whether CBT-I, with or without bright light therapy, improves insomnia, sleep, and circadian as well as other clinical outcomes, and cognitive functioning in youths with ADHD and whether these interventions can also lead to improvements in mood and other clinical symptoms, as well as cognitive functioning.
aged 10-24 years old;
ADHD diagnosis confirmed by DISC-IV;
DSM-5 diagnosis of insomnia disorder with an ≥ 9 (suggested cut-off for adolescents);
Being classified as evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, 12:00am or later for 15-17 years old [64], 10:56pm or later for 18-24 years old at least 3 nights per week in the past 3 months and as confirmed by a 7-day sleep diary;
Substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia, ASD, organic mental disorders, or intellectual disabilities;
Prominent medical condition affecting sleep (e.g., severe eczema, GERD);
Clinically diagnosed sleep disorder other than insomnia disorder, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both prescribed medications (e.g., hypnotics, steroids) and over-the-counter OTC medications (e.g., melatonin, Traditional Chinese Medicine, TCM), except for ADHD stimulants;
Parallel
CBT-I with Bright Light Group
BehavioralRefer to the arm description
CBT-I with Placebo Light Group
BehavioralRefer to the arm description
Changes in insomnia severity
Insomnia symptoms measured by Insomnia Severity Index (ISI). Insomnia Severity Index is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Remission of insomnia
Remission of insomnia is measured by Insomnia Severity Index (ISI), possible scores range from 0 to 20, with a score less than 9 (ISI \<9) defined as remission of insomnia.
Self-rated treatment response (insomnia)
Treatment response for insomnia is defined as by a reduction of Insomnia Severity Index (ISI) score from baseline ≧ 6. ISI scores range from 0-20.
Change in pre-sleep arousal
Pre-Sleep Arousal Scale (PSAS) is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Change in subjective sleep quality
Subjective sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index is a 19-item self-rated scale assessing sleep quality and sleep disturbances over the past month. Possible global scores range from 0 to 21, with higher scores indicating a worse outcome.
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The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Education University of Hong Kong
Collaborator
The Hong Kong Polytechnic University
Collaborator
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