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| Name | Class |
|---|---|
| Kwai Chung Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I group | Experimental | The intervention for the CBT-I group will involve five weekly 60-minute individual, face-to-face sessions of CBT-I. The treatment components aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia whilst considering the clinical context of ADHD and include: psychoeducation about sleep, circadian rhythm, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. |
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| TAU group | No Intervention | Participants will continue their usual clinical follow-up and receive standard treatment at the clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I group | Behavioral | Refer to the arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, one-week post-treatment and 3 month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: Adolescents aged 11-18 years old meeting the following inclusion criteria were invited to take part in the present study:
Exclusion Criteria: Adolescents were excluded if they met any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital | Hong Kong | Hong Kong | ||||
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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. | 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. | 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 | 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. | 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. | Baseline, one-week post-treatment and 3 month post-treatment |
| Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong |
| Hong Kong |
| Hong Kong |
| D001523 |
| Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |