CBT-I in Adolescents With ADHD

NCT07209969 | Active Not Recruiting

• 1 other identifier: KW/FR-21-131(163-09)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Insomnia; ADHD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in individual beliefs and attitude about sleep

  Baseline, one-week post-treatment and 3 month post-treatment

• Change in adolescent sleep hygiene

  Baseline, one-week post-treatment and 3 month post-treatment

• Change in ADHD symptoms (Self-report)

  Baseline, one-week post-treatment and 3 month post-treatment

• Change in anxiety symptoms

  Baseline, one-week post-treatment and 3 month post-treatment

• Change in depressive symptoms

  Baseline, one-week post-treatment and 3 month post-treatment

Study Arms (2)

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.

Behavioral: CBT-I group

TAU group

NO INTERVENTION

Participants will continue their usual clinical follow-up and receive standard treatment at the clinic.

Interventions

CBT-I group BEHAVIORAL

Refer to the arm description

CBT-I group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having a clinical diagnosis of ADHD made by health care professionals (psychiatrist, clinical psychologist, or educational psychologist) based on self-report;
• a DSM-5 diagnosis of insomnia disorder, and a score on ISI ≥ 9 (suggested cut-off for adolescents) (Chung et al., 2011);
• Those who agreed to keep the same dosage of medication throughout the study up till completion of follow up assessments.

You may not qualify if:

• A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorders, 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, based on self-reported medical history;
• On an optimal dosage of psychostimulant or nonstimulant ADHD medications for less than a month;
• 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 pharmacological and psychological treatment for insomnia;
• With hearing or speech deficit.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Kwai Chung Hospital: collaborator

Study Sites (2)

Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Design

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

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: April 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)