Sleep Treatment for Teens (RCT Phase)

Part of paid clinical trials in Piscataway, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07303959
Status
Recruiting
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Conditions

  • Sleep Problems
  • Suicidal Behavior
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment as usual (TAU) + ecological momentary assessment (EMA)
    Treatment as usual plus assessments via EMA
  • Experimental: Sleepio (TM) + Treatment as usual (TAU) + EMA
    Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

Primary Outcome Measure

Insomnia severity [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers University Behavioral HealthcarePiscatawayNew Jersey08854
Evan Kleiman
[email protected]
2153596148
Children's Hospital of The King's DaughtersNorfolkVirginia23507
Catherine Glenn
[email protected]
(757) 683-4458

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Rutgers University Behavioral Healthcare· Piscataway, NJChildren's Hospital of The King's Daughters· Norfolk, VA

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