Recruiting

CBT-I

Sponsor:

Indiana University

Code:

NCT06541886

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study Details

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 for adults and is sometimes also used for teens. Teens, parents, and health care providers helped to review and adapt CBT-I to form Teen CBT-I. Teen CBT-I includes most of the same content as CBT-I, with some changes to match teen biology and lifestyles.

The main questions this clinical trial aims to answer are:

  • Does Teen CBT-I improve insomnia symptoms in teens?

o Researchers will compare Teen CBT-I to the waitlist control condition to see if insomnia symptoms significantly improve in the treatment group.
  • Do teens and their parents find Teen CBT-I to be acceptable? o Researchers will examine Teen CBT-I acceptability ratings.

Teen CBT-I is hypothesized to improve insomnia symptoms in teens, and teens and parents are hypothesized to find Teen CBT-I to be acceptable.

Teen participants will be randomized to one of the two conditions: Teen CBT-I treatment or waitlist control. They will also complete assessments at three timepoints: Baseline (before treatment); post-intervention (after treatment); and follow-up (2 months after treatment). For each assessment, teen participants will:

  • Fill out questionnaires about their sleep, mood, and other areas
  • Keep daily sleep logs for one week
  • Wear an actigraph, a wrist-watch like device that records activity levels to determine sleep-wake patterns, for one week.

Parent participants will also be asked to complete questionnaires at each measurement point about their teen's sleep, mood, and other areas.

The intervention conditions are:

  • Teen CBT-I includes 4-6 one-hour individual virtual sessions with a therapist. It includes standard CBT-I content with some small changes to match teen biology and lifestyles. The main parts of this treatment include healthy sleep habits, only using the bed for sleep, keeping a recommended sleep schedule, changing negative thoughts about sleep, and learning ways to relax the mind and body for sleep.
  • Waitlist-control, in which teens will not receive any treatment for 8 weeks. After the second assessment, they will receive free access to an app-based CBT-I treatment which they can complete on their own.

Conditions

Insomnia

Study ID

NCT06541886

Start date

Apr 3, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teen CBT-I

Teens in this treatment condition will have an intake session and 6 treatment sessions virtually and individually with a therapist. The first session will include an introduction to Sleep Science and Insomnia Treatment. Middle sessions will include Healthy Sleep Habits, Setting a Sleep Schedule, Preparing the Mind and Body for Sleep, and Distinguishing the Sleep Space and Wake Space. The final session will be be centered on maintenance of treatment gains. Treatment will also include visual aids (e.g., slides) to convey didactic or psychoeducational material.

no intervention: Waitlist

Teens in the waitlist condition will still complete the same study measures and receive the same payment for taking part in the study, but they will not receive treatment from a therapist. Their treatment will begin after they have completed the second round of measures (i.e., 8 weeks after they complete the baseline assessment). After they have completed the second round of measures, they will be given free access to an app that provides guided insomnia treatment. While no live therapist is involved, the approach is similar to traditional CBT-I.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I was developed as a treatment for adults with insomnia. There are more than 100 studies showing that CBT-I is effective in treating insomnia in adults, and several studies suggest it is also effective in treating insomnia in teens.

Primary outcome measure

  • Teen-reported insomnia severity [ Time Frame: Baseline, Post-treatment (approximately 8 weeks after baseline), and 2 month follow up ]
  • Teen-reported treatment acceptability [ Time Frame: Post-treatment (approximately 8 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Maureen E McQuillan, PhD

317-944-7368memcquil@iu.edu

Sarah M Honaker, PhD

317-278-0570smhonake@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46220

More Information

Sponsor

Indiana University

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

  • Cognitive Behavioral Therapy for Insomnia
  • Adolescence
  • Randomized controlled trial
  • Efficacy
  • Stakeholders
  • Adaptation
  • Actigraphy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.