Can a sleep therapy designed for teens cure insomnia?
NCT ID NCT06541886
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a version of Cognitive Behavioral Therapy for Insomnia (CBT-I) that has been adapted specifically for teenagers. The treatment includes healthy sleep habits, a consistent sleep schedule, and relaxation techniques. Researchers will compare teens who receive this therapy to those on a waitlist to see if it reduces insomnia symptoms and is acceptable to teens and their parents.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for teens
- What this could lead to
- If it works, this could provide an effective, non-drug treatment option for teens with insomnia, improving their sleep and daily functioning.
- What could go wrong
- This is a small early-stage study with only 28 participants, so results may not apply to all teens. The waitlist control group may also show improvement over time, making it harder to prove the treatment's effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University School of Medicine
RECRUITINGIndianapolis, Indiana, 46220, United States
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