Adapted Cognitive Behavioral Therapy for Insomnia in Teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.