Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07303959

Sleep Treatment for Teens (RCT Phase)

Sleep Treatment for Teens

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Academic / Other
Sex
All
Age
14 Years – 18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research study is to compare (vs. treatment as usual) 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=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleepioSleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
BEHAVIORALTreatment as Usual (TAU)Treatment as usual as part of standard inpatient care, and any outpatient care received.

Timeline

Start date
2025-06-02
Primary completion
2025-12-30
Completion
2026-03-01
First posted
2025-12-26
Last updated
2025-12-26

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07303959. Inclusion in this directory is not an endorsement.