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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

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 limited. Preliminary evidence for the efficacy of CBT-I with adolescents is promising, but treatment protocols in existing trials are heterogeneous, making it difficult to characterize CBT-I for teens. In Aim 1 of this study, CBT-I was systematically adapted through collaboration with stakeholders (i.e., teens, parents, and behavioral sleep medicine providers across the country), making changes to the intervention tailored to teen biology and lifestyles.

Objective: The objective of this study is to test this adapted intervention (hereafter referred to as Teen CBT-I) in comparison to a waitlist control condition in adolescents with insomnia.

Hypotheses:

1. Teen CBT-I will reduce insomnia symptoms compared to a no treatment (waitlist) condition.
2. Teen CBT-I will be deemed acceptable by teens and parents.

Participants: Adolescents with insomnia (N=28) and their parents will be randomized to either Teen CBT-I (n=14) or the waitlist control condition (n = 14).

Recruitment: Parents of adolescents are recruited primarily via social media. Recruitment posts and images are boosted to both Facebook and Instagram using the Facebook Ads Manager system. We also advertise our study on Research Match and All IN for Health TrialX iConnect.

ResearchMatch.org is a national electronic, web-based recruitment tool that was created through the Clinical & Translational Science Awards Consortium in 2009 and is maintained at Vanderbilt University Medical Center. There is no cost for researchers at participating institutions in the ResearchMatch Network to use ResearchMatch for the purposes of conducting recruitment feasibility analysis or participant recruitment. The Vanderbilt University Medical Center IRB provides oversight for ResearchMatch as a recruitment tool.

iConnect is a HIPAA-compliant and secure public facing research recruitment platform provided by the Indiana Clinical and Translational Sciences Institute (Indiana University) consisting of a study trial listing and volunteer registry. This system is licensed by Indiana University from TrialX and is monitored by the Indiana University Information Technology Services (UITS) and University Information Security Office (ISO). Study Teams have access to their study listings and participant referrals based on a secure login. There is a small Administrative Team within the Indiana CTSI that manages the iConnect platform and has access to all study information, referrals, and registry volunteers. This online platform provides researchers with the ability to create a public facing webpage that can contain a brief prescreener and the ability for the public to refer themselves to the trial.

Across social media, research match, and All in for Health, recruitment posts and images describe the study and provide a link to an Interest Survey for parents to complete. Parents can then provide consent and contact information for their teen to also be contacted and invited to complete a recruitment survey.

Interest Survey:

The online surveys will provide additional information about the study and ask eligibility questions. Ineligible respondents will be informed of their status and will not be asked for any additional information. Respondents who are not ineligible* will be asked for contact information and demographic information.

Some, but not all, interested participants will be contacted and invited to complete the next step, an Eligibility and Consent Meeting.

*Some eligibility criteria will be assessed during the Eligibility and Consent meeting as they are more complex and require evaluation through an interactive call rather than a survey.

Eligibility and Consent Meeting:

Parent-teen dyads who completed the recruitment surveys and are not screened out will then be asked to meet with a research team member to further determine eligibility. Teen suicidal ideation will be evaluated, along with other comorbid conditions that may make the teen ineligible.

If the teen and parent are determined to be eligible for the study, an informed consent process will then be initiated. Parents and teens will be provided with more information about the study and the opportunity to ask questions, prior to deciding whether or not they would like to be part of the study. Enrolled participants will then proceed to the baseline assessment.

Randomization Once the baseline measures are completed, the teen-parent dyad will be randomized to one of the two conditions using a randomization module in REDCap. Randomization will be stratified based on age so that there is the same number of younger teens (ages 13-15) and older teens (ages 16-18) in each condition.

Conditions Participants randomized to Teen CBT-I will meet individually with a therapist for a virtual, one-hour session. Each session will be administered free of charge. Most of each treatment session will be with just the therapist and the teen. However, the parent will be asked to join for the last ten minutes of each appointment to keep the parent informed about the treatment plan. If they wish, teens can decide to involve their parent earlier in the session.

Teen CBT-I Teens in this treatment condition will have an intake session and between 4 to 6 treatment sessions. 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 from the teen's hang out space. The last session will be centered on maintenance of treatment gains. Treatment will include visual aids (e.g., a powerpoint) to convey didactic or psychoeducational material.

Waitlist Control Teens in the waitlist condition will still complete the same study measures, 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 completing the baseline measures). 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.

Fidelity Monitoring Audio and video will be recorded during the treatment sessions. The purpose of this is so that supervisors can review some of the sessions to help with therapist training, and to make sure that the therapist is following the treatment protocol. These recordings will only be reviewed by the study team to monitor the therapist, and recordings will be stored securely. No one outside of the study will have access to these recordings. The recordings will be deleted after the 2-month follow up. De-identified (i.e., without names, location) transcripts of the sessions will be kept. If a teen-parent dyad is not comfortable with recording of the sessions, they can opt out, meaning that they can still be in the study, but their treatment sessions will not be recorded. There is an opt-in / opt-out component within the informed consent process.

Analysis Plan Linear regression modeling will be used to assess pre- and post-intervention changes in clinical outcomes, reporting effect sizes (Cohen's d) and controlling for relevant covariates.

Implementation outcomes will be reported descriptively. With n=28 (comparing two groups in multiple pairwise comparisons), 80% power, and α = .05, there is adequate power to detect an effect size of d = 1.00, which is consistent with prior research testing CBT-I for teens and adults, with effect sizes ranging from d = 1.00-1.22.

Potential Risks Potential risks include confidentiality breaches and discomfort from wearing the actigraph, a wrist-watch like device that will be used to measure adolescent sleep outcomes.

The risk of loss of confidentiality will be minimized by the research team. Efforts will be made to keep personal information confidential, and only de-identified group data will be shared or published to keep participant identity confidential. Personal information would only be disclosed if required by law.

Completed questionnaires will be stored in a secure, electronic database that is accessible only by study team members approved by the Office for Protection of Human Subjects.

One exception to confidentiality would be if there is concern about the health and safety of a teen. This risk would be immediately discussed with the teen and parent and reported to the necessary authorities to ensure safety. An example of this would be if a teen indicated they were being abused or that they were planning to hurt themselves or someone else.

Another exception to confidentiality is that the university and federal offices that are in charge of protecting the rights of research participants and the quality of research may, in rare instances, need to inspect or copy a researcher's data. This includes the Indiana University Institutional Review Board and the Office for Human Research Protections.

Although extremely rare, if a participant experiences skin discomfort from the actigraph, they can wear the device over a shirt.

It is also possible that participants could lose or damage the actigraph. Research staff will explain the proper use and importance of these devices to prevent such risks, but the risk is still possible. If a participant loses or damages the actigraph, they will not be held financially responsible and will not be excluded from the study. Data within the actigraph can only be accessed with specialized software. In addition, no identifiers are included in the actigraphic output aside from the participant's research ID.

Informed consent. The process will be conducted in a location that is considered private and controlled. The consenting process will include the study purpose, inclusion/exclusion criteria, enrollment goal, timeline and study interventions. The adolescent participant will assent for the study following IRB guidelines along with obtaining consent from adult participants. All participants will be asked to provide verbal consent/assent prior to participation in any study activities or interventions.

Potential benefits of the proposed research to human subjects and others Benefits to participants may include improvement in insomnia symptoms. The potential benefit to society is determining whether the adapted treatment protocol is efficacious. If it is, it can then be used more widely to improve outcomes for adolescents with insomnia. This can lead to improved functioning in adolescents with insomnia and intervention success for providers and caregivers.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maureen E McQuillan, PhD; Phone Number: 317-944-7368; Email: memcquil@iu.edu
• Study Contact Backup: Name: Sarah M Honaker, PhD; Phone Number: 317-278-0570; Email: smhonake@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46220
      • Recruiting
      • Indiana University School of Medicine
      • Contact: Maureen E McQuillan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teen-reported insomnia severity	assessed via the PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance scale, which has been established as reliable and valid with adolescents. Possible scores on this scale range from 10 - 50, where higher scores reflect more severe insomnia.	Baseline, Post-treatment (approximately 8 weeks after baseline), and 2 month follow up
Teen-reported treatment acceptability	based on the widely used Client Satisfaction Questionnaire, which assesses treatment feasibility, satisfaction, and perceived helpfulness. Possible scores on this scale range from 8-40, where higher scores reflect higher acceptability ratings.	Post-treatment (approximately 8 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teen-reported sleep onset latency	Based on sleep diary	Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported wake after sleep onset	Based on sleep diary	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported night wakings	Number of night wakings, based on sleep diary	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported sleep efficiency	Average of total sleep time divided by time spent in bed each night, based on information provided by teen in the sleep diary	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Sleep efficiency	Average of total sleep time divided by time spent in bed each night, as measured via the actigraph	assessed at Baseline and Post-treatment (approximately 8 weeks after baseline)
Wake after sleep onset	Based on actigraphy	assessed at Baseline and post-treatment (approximately 8 weeks after baseline)
Teen Mood	Depressive Symptoms from the PROMIS (Patient-Reported Outcomes Measurement Information System) measure. Possible scores range from 8 to 40, where higher scores reflect more depressive symptoms.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen Stress	Teen report on the PROMIS (Patient-Reported Outcomes Measurement Information System) Psychological Stress Experiences measure. Possible scores range from 8 to 40, where higher scores reflect more stress.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen Daytime Sleepiness	Teen report on the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment Scale. Possible scores range from 8 to 40, where higher scores reflect more daytime impairment.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported sleep hygiene	pediatric sleep practices questionnaire - short form. Possible scores range from 7 to 35, where higher scores reflect better sleep hygiene.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported parent-teen conflict about sleep	"How much did you and your parent argue about sleep in the past week ?" Using a 1-5 Likert scale, where higher scores reflect more conflict.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Parent-reported parent-teen conflict about sleep	"How much did you and your teen argue about sleep in the past week ?" Using a 1-5 Likert scale, where higher scores reflect more conflict.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Parent-reported insomnia symptoms	using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance scale. Possible scores range from 10 - 50, where higher scores reflect more severe insomnia.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Parent-reported daytime sleepiness	using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) sleep related impairment scale. Possible scores range from 8 to 40, where higher scores reflect more severe daytime impairment.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Parent perception of adolescent mood	using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) depressive symptoms scale. Possible scores range from 6 to 30, where higher scores reflect more teen depressive symptoms.	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Parent-reported school attendance	Based on two items: "In the past 2 weeks, how many days has your child missed school because of difficulty sleeping?" AND "In the past 2 weeks, how many days has your child been late to school because of difficulty sleeping?"	assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up
Teen-reported treatment adherence	via adolescent report on sleep diary	assessed at Post-treatment (approximately 8 weeks after baseline) and at 2-month follow up
Treatment engagement	based on session attendance and treatment completion	assessed at post-treatment approximately 8 weeks after baseline
Adverse treatment effects	Report of any car accidents, suicidality, or risky behaviors that could be attributed to sleep restriction and/or reductions in daytime alertness	assessed at post-treatment approximately 8 weeks after baseline
Parent-reported treatment acceptability	based on the widely used Client Satisfaction Questionnaire, which assesses treatment feasibility, satisfaction, and perceived helpfulness. Possible scores on this scale range from 8-40, where higher scores reflect higher acceptability ratings.	assessed at post-treatment approximately 8 weeks after baseline

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: American Academy of Sleep Medicine; Nyxeos Consulting
• Investigators: Principal Investigator: Sarah M Honaker, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Efficacy; Randomized controlled trial; Adolescence; Adaptation; Actigraphy; Cognitive Behavioral Therapy for Insomnia; Stakeholders
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 13047; 249-SR-21 (Other Grant/Funding Number: American Academy of Sleep Medicine Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No