Actively Recruiting
Sleep Treatment for Teens (RCT Phase)
Led by Rutgers, The State University of New Jersey · Updated on 2025-12-26
80
Participants Needed
2
Research Sites
38 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sleep Treatment for Teens (RCT Phase)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14-18 years old
- Recent hospitalization due to suicide risk, including attempts or suicidal ideation with intent or plan
- Clinically significant insomnia symptoms with SCI scores 64 16
- Access to or willingness to use a compatible smart device (iOS 10.3+/Android 8.0+); loaner device offered if needed
You will not qualify if you...
- Prior treatment with cognitive behavioral therapy for insomnia
- Diagnosis of bipolar disorder
- Primary substance use disorder requiring alternative treatment
- Factors reducing ability to consent or complete study (e.g., psychosis, violence, severe cognitive impairment, non-English speaking)
- Unwillingness to wear wrist actigraphy or complete ecological momentary assessment surveys
- Lack of parental permission or consent if minor
- Having a sibling already enrolled in the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, United States, 08854
Actively Recruiting
2
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
E
Evan Kleiman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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