Status:
RECRUITING
Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
American Academy of Sleep Medicine
Nyxeos Consulting
Conditions:
Insomnia
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
The goal of this study is to test an adapted treatment for teen insomnia in comparison to a waitlist condition. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an intervention that was developed ...
Detailed Description
Background: Cognitive Behavioral Therapy for Insomnia (CBT-I) has been well-established as an efficacious and first-line treatment for insomnia in adults, but research on its use with adolescents is l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06541886
Start Date
April 3 2025
End Date
December 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46220