NCT07767617

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Aug 2029

Study Start

First participant enrolled

August 10, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

3.1 years

First QC Date

August 11, 2026

Last Update Submit

August 20, 2026

Conditions

InsomniaADHDEveningnessChronotypeTreatment Effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, mid-treatment (week 4), one-week post-treatment, 1-month follow-up, and 6-month follow-up

Secondary Outcomes (45)

  • Remission of insomnia

    One-week post-treatment, 1-month follow-up, and 6-month follow-up

  • Self-rated treatment response (insomnia)

    One-week post-treatment, 1-month follow-up, and 6-month follow-up

  • Change in pre-sleep arousal

    Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up

  • Change in subjective sleep quality

    Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up

  • Change in sleep-related dysfunctional beliefs and attitudes

    Baseline, one-week post-treatment, 1-month follow-up, and 6-month follow-up

  • +40 more secondary outcomes

Study Arms (3)

CBT-I with Bright Light Therapy

EXPERIMENTAL

The intervention for the CBT-I plus bright light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I, together with daily home-based morning bright light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD, and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention. Bright light therapy will be administered at home using a portable light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.

Behavioral: CBT-I with Bright Light Group

CBT-I with Placebo Light Therapy

EXPERIMENTAL

The intervention for the CBT-I plus placebo light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I delivered, together with daily home-based morning placebo light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention. Placebo light therapy will be administered at home using a portable placebo light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.

Behavioral: CBT-I with Placebo Light Group

Waitlist control

NO INTERVENTION

Participants in the waiting-list control group will not receive any active intervention during the study period but will complete the same set of assessments as the intervention groups at baseline and at post-waiting. This group will serve as a comparator for evaluating changes in outcomes over time. Participants will continue with their usual care and clinical follow-up as appropriate during the waiting period.

Interventions

CBT-I with Bright Light GroupBEHAVIORAL

Refer to the arm description

CBT-I with Bright Light Therapy
CBT-I with Placebo Light GroupBEHAVIORAL

Refer to the arm description

CBT-I with Placebo Light Therapy

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • An adolescent who meets the following criteria will be eligible for taking part in this study:
  • 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;
  • Written informed consent from the participant and their parent/guardian (for those aged under 18);
  • Being able to comply with the study protocol;
  • Either not on ADHD medication or stabilized on medications for at least 6 months.

You may not qualify if:

  • An adolescent who meets one or more of the following criteria will be excluded from the study:
  • 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;
  • Ongoing psychological treatment for sleep problems;
  • With hearing or speech deficit;
  • Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong, Hong Kong,

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Shirley X Li, DClinPsy

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley X Li, DClinPsy

CONTACT

39177035shirley.li@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations

HK(1)