Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
NCT06541886

Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study

Led by Indiana University · Updated on 2026-02-27

28

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

A

American Academy of Sleep Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study

Who Can Participate

Age: 13Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents aged 13 to 18 years in middle or high school with chronic insomnia disorder currently or in the past year
  • Living in a state where the supervising provider is licensed to practice psychology (specified states listed in study)
  • Sufficient English language skills to participate and provide consent
  • Reliable internet access for virtual visits with audio and video
  • Parent or caregiver lives in the home at least 50% of the time and plays a parental role, able to attend last 10 minutes of treatment sessions if assigned
Not Eligible

You will not qualify if you...

  • Use of sleep aids that is inconsistent or effective enough to eliminate insomnia symptoms, unless dose and frequency remain stable with symptoms present
  • Prior participation in Aim 1 of the DREAM IT study
  • Acute, unstable, or untreated medical or psychiatric conditions including substance use disorders; exclusion includes Autism Spectrum Disorder, Epilepsy, Schizophrenia, and Bipolar Disorder
  • Comorbid delayed sleep phase disorder or other untreated sleep disorders such as restless legs syndrome, obstructive sleep apnea, or nightmare disorder
  • Active suicidal ideation with plan and intent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46220

Actively Recruiting

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Research Team

M

Maureen E McQuillan, PhD

CONTACT

S

Sarah M Honaker, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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