Status:
ACTIVE_NOT_RECRUITING
CBT-I in Adolescents With ADHD
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Kwai Chung Hospital
Conditions:
Insomnia
ADHD
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity, affecting individuals across the l...
Detailed Description
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 (interve...
Eligibility Criteria
Inclusion
- Adolescents aged 11-18 years old meeting the following inclusion criteria were invited to take part in the present study:
- 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.
Exclusion
- Adolescents were excluded if they met any of the following criteria:
- 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.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07209969
Start Date
April 1 2023
End Date
October 31 2025
Last Update
October 7 2025
Active Locations (2)
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1
Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital
Hong Kong, Hong Kong
2
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong