Cognitive Behavioral Therapy for Insomnia in Teens with ADHD
Efficacy of Cognitive Behaviour Therapy for Insomnia (CBT-I) in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Trial
This study is testing if cognitive behavioral therapy for insomnia can help teenagers with ADHD sleep better and improve their ADHD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT06351930 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in adolescents aged 12-18 who have both ADHD and insomnia. Participants will be randomly assigned to receive either CBT-I combined with usual care or just usual care alone. The study will assess sleep quality and ADHD symptoms at multiple time points, including baseline, one week post-treatment, and three months after treatment. The trial aims to address the unique sleep challenges faced by adolescents with ADHD and insomnia, providing a tailored intervention to improve their overall mental health.
Who should consider this trial
Good fit: Ideal candidates are Cantonese-speaking adolescents aged 12-18 with a confirmed diagnosis of ADHD and insomnia.
Not a fit: Patients with current substance abuse issues or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and ADHD symptoms in adolescents, leading to better mental health outcomes.
How similar studies have performed: Previous studies have shown promise for behavioral sleep interventions in children with ADHD, suggesting potential success for this approach in adolescents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cantonese-speaking adolescent aged 12-18 years old; 2. A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV); 3. Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents); 4. Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18); 5. Being able to comply with the study protocol; 6. 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: 1. 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; 2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema, gastro-oesophageal reflux disease); 3. 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; 4. 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; 5. Receiving ongoing psychological treatment for sleep problems; 6. With hearing or speech deficit; 7. 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).
Where this trial is running
Hong Kong and 1 other locations
- Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital — Hong Kong, Hong Kong (Recruiting)
- Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Shirley X Li, PhD, DClinPsy
- Email: shirley.li@hku.hk
- Phone: 852-39177035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.