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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Refer to the arm description
Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital
Hong Kong, Hong Kong
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
Change in insomnia symptoms
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in individual beliefs and attitude about sleep
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 and 3 month post-treatment
Change in adolescent sleep hygiene
The Revised Adolescents Sleep Hygiene Scale (ASHSr) is used to measure adolescent sleep hygiene. It comprises 33 self-report items, categorizing into six subscales: physiological, sleep environment, cognitive/emotional, sleep stability, daytime sleep, and behavioral arousal. Adolescents rate the frequency of their sleep-related behaviors over the past month using a 6-point scale, where 1 corresponds to "always" and 6 to "never." Subscale scores are computed using means, and these scores range from 1 to 6. Higher scores on the subscales indicate better sleep hygiene.
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
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 and 3 month post-treatment
Change in anxiety symptoms
The Generalized Anxiety Disorder 7-item scale (GAD-7) will be used to measure generalized anxiety symptoms in the past 2 weeks
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in depressive symptoms
The Patient Health Questionnaire - 9 (PHQ-9) will be used to measure the presence and severity of depression in the past 2 weeks.
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
Change in emotion regulation ability
The Difficulty in Emotion Regulation Scale (DERS; (Gratz \& Roemer, 2004) will be used to assess six domains of emotion regulation ability.
Time frame: Baseline, one-week post-treatment and 3 month post-treatment
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