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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Sleepio | Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
| BEHAVIORAL | Treatment 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.