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.
An assessor-blind, three-arm, parallel-group, randomised controlled trial will be conducted in youths with ADHD, comorbid insomnia, and evening chronotype. Eligible participants will be randomised to one of three conditions: CBT-I plus bright light therapy, CBT-I plus placebo light therapy, or a waiting-list control group. The active intervention will consist of six weekly group-based CBT-I sessions, with daily morning light treatment beginning from the second week of intervention. Participants in the bright light therapy group will receive active blue-green light treatment delivered by light therapy glasses, whereas those in the CBT-I only group will receive placebo light therapy delivered via the same device. Assessments will be conducted at baseline and post-treatment for all the study participants, and additionally 1-month follow-up and 6-month follow-up for those in the two active intervention groups to evaluate the immediate and maintenance effects of the treatment. Outcome measures will include self-reported, clinician-rated, and objective assessments of sleep, circadian rhythm, arousal, ADHD symptoms, mood symptoms, cognitive functioning, and other daytime functioning outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Refer to the arm description
Refer to the arm description
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong, Hong Kong,
Hong Kong, Hong Kong
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.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
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.
Time frame: One-week post-treatment, 1-month follow-up, and 6-month follow-up
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.
Time frame: One-week post-treatment, 1-month follow-up, and 6-month follow-up
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.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
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.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in sleep-related dysfunctional beliefs and attitudes
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in arousal predisposition
Arousal predisposition measured by the Arousal Predisposition Scale (APS). Possible scores range from 1 to 48. Arousal Predisposition Scale is a self-rated scale assessing an individual's tendency to become aroused in response to internal or external stimuli. Higher scores indicate greater arousal predisposition.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of sleep hygiene and practice
Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of sleep diary measure (total sleep time, TST)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of sleep diary measure (sleep onset latency, SOL)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of sleep diary measure (wake after sleep onset, WASO)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of sleep diary measure (sleep efficiency, SE)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, possible value range from 0-100%.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Self-Report Circadian Typology
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report rating scale measuring circadian preference (typology). Possible scores range from 16 to 89, with lower scores indicating preference towards eveningness. Based on the conventional cut off, having a Morningness-Eveningness Questionnaire score of 16-41 is considered eveningness.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Self-Report Chronotype Measures
Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in ADHD symptoms (Self-report)
The Adult ADHD Self-Report Scale (ASRS) v1.1 Symptom Checklist is an 18-item self-administered questionnaire to screen for ADHD symptoms in both community surveys and clinical settings based on criteria of the DSM-IV-TR. The questionnaire asks participants to rate how often a symptom of inattention or hyperactivity has occurred during the past 6 months using a scale from 0 (never) to 4 (very often). The total score on this scale can range from 0 to 72, with higher scores indicating more ADHD symptomology.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in subjective neuropsychological difficulties
Subjective awareness of neuropsychological difficulties measured by the Subjective Awareness of Neuropsychological Deficits Questionnaire for Children (SAND-C). This self-rated measure assesses perceived cognitive difficulties in daily life. The possible score ranges from 1-4. Higher scores indicate a worse outcome, reflecting greater perceived neuropsychological difficulties.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Self-report Mood Symptoms
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores.
Time frame: Baseline, mid-treatment (week 2, week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in self-report emotional states of depression, anxiety and stress
Depression Anxiety Stress Scales (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three Depression Anxiety Stress Scales contains 14 items. Scale score ranges from 0 to 42. Higher scores suggest more depression, anxiety and stress, respectively.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in impulsive behavior
Impulsive behaviour traits measured by the Short UPPS-P Impulsive Behavior Scale (SUPPS-P). This self-rated scale assesses multiple facets of impulsive behaviour. The Short UPPS-P Impulsive Behavior Scale (SUPPS-P) features a subscale score range of 4 to 16 for each of its five distinct impulsivity traits. Higher scores indicate a higher level of impulsive behavior.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in impulsivity
Impulsiveness measured by the Barratt Impulsiveness Scale, Version 11 (BIS-11). This self-rated scale assesses attentional, motor, and non-planning impulsiveness. Possible total scores range from 30 to 120, with higher scores indicating higher impulsivity.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of daytime fatigue
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. A higher score represents a higher level of fatigue symptoms.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in daytime sleepiness
Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change of Overall Severity of Clinical Symptoms
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluates the severity of psychopathology. The score is given on a seven-point scale, with score ranging from 0-7, and higher values indicating higher severity of illness.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Treatment response (clinician-rated)
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Clinical Global Improvement Scale (CGI-I) evaluates change from the initiation of treatment. Clinician rated treatment response score ranges from 0-7 and is defined as Clinical Global Improvement Scale score ≦ 2.
Time frame: One-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Depressive Symptoms (Assessor-rated)
Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.
Time frame: Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Objective Sleep Measures - Time in Bed (TIB)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Objective Sleep Measures - Total Sleep Time (TST)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Objective Sleep Measures - Sleep Onset Latency (SOL)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, range from 0-100%
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - L5
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the nonparametric circadian rhythm analysis method - start times and average activity of L5 (i.e. five hours with least activity).
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - M10
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the nonparametric circadian rhythm analysis method - start times and average activity of M10 (i.e. 10 h with maximal activity).
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Nonparametric circadian rhythm analysis - relative amplitude (RA)
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the nonparametric circadian rhythm analysis method - relative amplitude (RA), which is calculated using L5 and M10 to give a nonparametric description of amplitude.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Cosinor Analysis - acrophase
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the cosinor analysis method - acrophase (the peak of the sine wave).
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Cosinor Analysis - amplitude
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the cosinor analysis method - amplitude (the difference between the wave peak and trough).
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment,1-month follow-up, and 6-month follow-up
Change in Actigraphic Circadian Measures using Cosinor Analysis - mesor
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the cosinor analysis method - mesor.
Time frame: Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up
Change in Objective Circadian Measures: Dim-light melatonin onset (DLMO)
Dim-light melatonin onset (express as time value hh:mm) is determined by 10-hours salivary melatonin collected at 30-minutes interval. Melatonin is assayed by gas chromatography-mass spectrometry. Data will be collected in a subset of sample.
Time frame: Baseline and 1-month follow-up
Change in neural sensitivity to light
Neural sensitivity to light measured by pupillary light response (PLR). PLR is based on change in pupil diameter in response to standardized light stimuli.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in impulsive decision-making
Impulsive decision-making measured by the Delay Discounting Task (DDT). This behavioural task assesses preference for smaller immediate rewards over larger delayed rewards. Greater preference for larger delayed rewards indicates a better outcome, whereas steeper delay discounting indicates a worse outcome.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in decision-making under uncertainty
Decision-making under uncertainty measured by the Beads Task. This behavioural task assesses probabilistic reasoning and decision-making under uncertainty. More adaptive evidence gathering before decision-making generally indicates a better outcome.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in information sampling and reflection impulsivity
Information sampling and reflection impulsivity measured by the Information Sampling Task (IST). This behavioural task assesses the amount of information gathered before making a decision. Greater adaptive information sampling generally indicates a better outcome.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in working memory
Working memory measured by the Digit Span Task. This test assesses verbal short-term memory and working memory capacity. Higher scores indicate a better outcome.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in sustained attention
Sustained attention measured by the Continuous Performance Task (CPT). This test assesses the ability to maintain attention to target stimuli over time. Better accuracy and fewer omission and commission errors indicate a better outcome.
Time frame: Baseline, 1-month follow-up, and 6-month follow-up
Change in ERP components on the Cued Go/NoGo task
The ERP components including CNV, NoGo N2, and NoGo P3 will be examined between the treatment group and control, in baseline, post-treatment and followup sessions.
Time frame: Baseline, 1-month follow-up
Change in ERP components on the Balloon Analogue Risk Task
The ERP components including feedback-related negativity (FRN) and P300 amplitudes to both negative and positive feedback will be examined on the Balloon Analogue Risk Task.
Time frame: Baseline, 1-month follow-up
Change in ERP components on the Stop Signal Task
The ERP components, including N2 and P3 will be examined on the Stop Signal Task.
Time frame: Baseline, 1-month follow-up
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