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NCT06541886 · ClinicalTrials.gov registry record · NA
Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
A NA study of Insomnia, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06541886: Recruiting NA study of Insomnia, sponsored by Indiana University.
NCT06541886 is a NA study of Insomnia that is actively recruiting participants, run by Indiana University. The registered enrollment target is 28 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06541886, a NA study of Insomnia, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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 recomme
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2025-04-03 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06541886 shows while recruiting
NCT06541886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT06541886 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06541886 about?
NCT06541886 is a clinical study titled "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...
What is the current status of trial NCT06541886?
This trial is currently recruiting. It is a NA study. The enrollment target is 28 participants. The study started on 2025-04-03. Estimated completion is 2026-12.
What conditions does trial NCT06541886 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT06541886?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06541886?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541886 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06541886's enrollment target sits among peer trials
28 128th of 151 higher than 22 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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