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Completed

NCT Number: NCT06351930

CBT for Insomnia in Adolescents With ADHD

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.

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Key information

Conditions

Insomnia ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital, Hong Kong

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About this study

A parallel-group, randomised controlled trial will be conducted in adolescents with comorbid ADHD and insomnia. Eligible participants will be randomised to either CBT-I + UC or UC condition. Assessments will be conducted at baseline, one-week post-treatment, and post-treatment 3-month. A random subset of the sample (estimated 15 participants per group) will be assessed for sleep objectively using actigraphy for 7 consecutive days at baseline and one-week post-treatment. Participants in the control group will be offered CBT-I after 3-month follow-up. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cantonese-speaking adolescent aged 12-18 years old;
  • A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
  • Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents);
  • Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
  • Being able to comply with the study protocol;
  • Those who are not on ADHD medication or have been stabilized on psychostimulant or nonstimulant ADHD medications (maintaining the optimal medication dosage for at least 6 months).

Exclusion criteria

  • A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorder, organic mental disorders, or intellectual disabilities;
  • Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema, gastro-oesophageal reflux disease);
  • Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
  • Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g., hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
  • Receiving ongoing psychological treatment for sleep problems;
  • With hearing or speech deficit;
  • In the opinion of the research clinician, having a clinically significant suicidality (e.g., with suicidal ideation with a plan or a suicide attempt in the recent one month), and/or endorsing "nearly everyday" for item 9 (suicidal thoughts) in the Patient Health Questionnaire - 9 (PHQ-9).

Treatment and study plan

CBT-I + UC group

Behavioral

Refer to the arm description

Primary outcomes

  1. Change in Insomnia Symptoms

    Time frame: Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.

    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.

Secondary outcomes

  1. Change in ADHD Symptoms (Self-report)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    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.

  2. Change in Internalising and Externalising Symptoms (Parent-rated)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    The Strengths and Difficulties Questionnaire (SDQ) - parent report is a widely used and validated screening questionnaire to measure emotional and behavioural problems in adolescents. It consists of 25 items covering five subscales relating to emotional problems, peer problems, conduct problems, hyperactivity, and prosocial behaviour. A higher score of the scales indicates a higher severity of the problem, except for prosocial behaviour scale.

  3. Change in depressive symptoms (Self-report)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Patient Health Questionnaire - 9 (PHQ9) consists of nine items to assess the frequency of depressive symptoms in the past 2 weeks. Higher scores suggest more severe depressive symptoms.

  4. Change in anxiety symptoms (Self-report)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report measure of generalised anxiety symptoms in the past 2 weeks. Higher scores suggest more severe anxiety symptoms.

  5. Change in Sleep Diary Measure - Time in Bed (TIB)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours

  6. Change in Sleep Diary Measure - Total Sleep Time (TST)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours

  7. Change in Sleep Diary Measure - Sleep Onset Latency (SOL)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins

  8. Change in Sleep Diary Measure - Wake After Sleep Onset (WASO)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins

  9. Change in Sleep Diary Measure - Sleep Efficiency (SE)

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    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, %

  10. Change in Objective Sleep Measures - Time in Bed (TIB)

    Time frame: Baseline and one-week post-treatment

    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours. A subset of sample will complete actigraphic assessment.

  11. Change in Objective Sleep Measures - Total Sleep Time (TST)

    Time frame: Baseline and one-week post-treatment

    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours. A subset of sample will complete actigraphic assessment.

  12. Change in Objective Sleep Measures - Sleep Onset Latency (SOL)

    Time frame: Baseline and one-week post-treatment

    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins. A subset of sample will complete actigraphic assessment.

  13. Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)

    Time frame: Baseline and one-week post-treatment

    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins. A subset of sample will complete actigraphic assessment.

  14. Change in Objective Sleep Measures - Sleep Efficiency (SE)

    Time frame: Baseline and one-week post-treatment

    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, %. A subset of sample will complete actigraphic assessment.

  15. Change in Individual Beliefs and Attitude about Sleep

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    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.

  16. Change in Adolescent Sleep Hygiene

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    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.

  17. Change in Quality of Life

    Time frame: Baseline, one-week post-treatment and post-treatment 3 month

    KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Kwai Chung Hospital

Registry information

Official study title

Efficacy of Cognitive Behaviour Therapy for Insomnia (CBT-I) in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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