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NCT05397353 · ClinicalTrials.gov registry record · NA
Sleep Treatment for Teens
A NA study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT05397353: Completed NA study, sponsored by Rutgers, The State University of New Jersey.
NCT05397353 is a NA study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05397353, a NA study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this research study is to test a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
Primary Outcome
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
Interventions
- OTHER Sleepio (TM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2025-04-04 |
| Phase | NA |
What the finished NCT05397353 record still lists
NCT05397353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Sleepio (TM) is the first listed.
NCT05397353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05397353 about?
NCT05397353 is a clinical study titled "Sleep Treatment for Teens". The purpose of this research study is to test a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the hig...
What is the current status of trial NCT05397353?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2023-02-10. Estimated completion is 2025-04-04.
What interventions are being tested in trial NCT05397353?
The interventions under investigation include: Sleepio (TM) (OTHER).
Who is sponsoring clinical trial NCT05397353?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05397353's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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