Adapted Cognitive Behavioral Therapy for Insomnia in Teens
Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
This study is testing a new version of therapy for insomnia designed for teens to see if it helps them sleep better compared to those who aren't getting the treatment right away.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06541886 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate an adapted version of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for adolescents, referred to as Teen CBT-I. The intervention will be compared to a waitlist control group to assess its effectiveness in reducing insomnia symptoms among teens aged 13-18. The adaptation process involved collaboration with teens, parents, and healthcare providers to ensure the treatment aligns with adolescent biology and lifestyles. Researchers will also assess the acceptability of Teen CBT-I from both teens and their parents.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13-18 who meet the diagnostic criteria for Chronic Insomnia Disorder.
Not a fit: Patients who do not have insomnia or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for adolescents suffering from insomnia.
How similar studies have performed: Preliminary evidence suggests that adaptations of CBT-I for adolescents are promising, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents (13-18 years) who are in either middle school or high school and meet ICSD-3 diagnostic criteria for Chronic Insomnia Disorder, currently or in the past year, based on self-reported insomnia symptoms, using a screening checklist. * Reside in a state where Dr. McQuillan (supervising provider) is licensed to practice psychology (with PsyPact) which are the following states: Alabama, Arizona, Arkansas, Colorado, Commonwealth of the Northern Mariana Islands, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. * Sufficient English language proficiency for consent and study participation * Reliable internet access to attend virtual visits with audio and video * Parents or other caregivers of these adolescents (hereafter referred to as a parent) must live in the home with the identified adolescent at least 50% of the time and must report playing a parental role for that adolescent. The parent must also be able to attend the final 10 minutes of each treatment session, if the teen is randomized to a treatment condition. Exclusion Criteria: * Sleep aid use that is either inconsistent (e.g., used some but not all nights) and cannot be discontinued OR consistent and effective enough that the teen no longer has insomnia symptoms while using it. If a teen agrees to keep the dose and frequency of sleep aid use consistent throughout the treatment and still has insomnia symptoms at baseline, they are not ineligible. * Prior participation in Aim 1 of DREAM IT study (e.g., participation in an Aim 1 focus group). * Comorbid medical or psychiatric conditions, including substance use disorders, that are acute, unstable, or untreated. Individuals with Autism Spectrum Disorder, Epilepsy, Schizophrenia, and Bipolar Disorder will be excluded. * Comorbid delayed sleep wake phase disorder or other active/untreated sleep disorders, including RLS, OSA, and Nightmare disorder * Active suicidal ideation with plan and intent
Where this trial is running
Indianapolis, Indiana
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Sarah M Honaker, PhD — Indiana University
- Study coordinator: Maureen E McQuillan, PhD
- Email: memcquil@iu.edu
- Phone: 317-944-7368
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.