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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06541886
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia (CBT-I) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 3, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46220
Maureen E McQuillan, PhD

Find similar trials in Indianapolis, IN

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Indiana University School of Medicine· Indianapolis, IN

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