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NCT Number: NCT07303959

Sleep Treatment for Teens (RCT Phase)

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University Behavioral Healthcare, Piscataway, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Age 14-18 years old.
  • Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using an abbreviated version of the semi-structured and well-validated Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017).
  • Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable
  • Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment/follow-up phase.

Adolescents will be excluded based on the following exclusion criteria:

  • Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
  • Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.
  • Substance use disorder that is primary to insomnia which would require alternative treatment.
  • Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed violence; severe cognitive impairment, non-English speaking).
  • Unwillingness to wear wrist actigraphy or complete the EMA surveys.
  • Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all adolescents). Eligibility will not be based on biological sex, gender identity, race, or ethnicity. These variables will be assessed during screening to compare those who are and are not eligible.
  • Having a sibling who has enrolled in the study.

Treatment and study plan

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.

Primary outcomes

  1. Insomnia severity

    Time frame: Up to 12 weeks

    Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 12 weeks to match assessment with the TAU group).

  2. Suicidal thoughts

    Time frame: Up to 12 weeks

    Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.

Secondary outcomes

  1. Sleep efficiency

    Time frame: Daily through study completion, up to 12 weeks

    Sleep efficiency (SE), percent of time in bed spent asleep, assessed via Actiwatch.

  2. Sleep Onset Latency

    Time frame: Daily throughout the study (12 weeks)

    Sleep onset latency (SOL): how many minutes it takes to fall asleep, assessed via Actiwatch device

  3. Daily Suicidal Thoughts

    Time frame: Daily through study completion, up to 12 weeks

    Daily reports of suicide ideation from EMA

  4. Wake after sleep onset

    Time frame: Daily through study completion, up to 12 weeks

    Wake after sleep onset (WASO): total amount of time awake during the night, assessed via Actiwatch wearable.

  5. Subjective sleep quality

    Time frame: Daily through study completion, up to 12 weeks

    Sleep quality: subjective ratings on 1=very poor to 5=very good, assessed via ecological momentary assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Kleiman, PhD

CONTACT

[email protected]

848-445-2345

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Children's Hospital of The King's Daughters
  • National Institute of Mental Health (NIMH)
  • Old Dominion University

Registry information

Official study title

Sleep Treatment for Teens

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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