Digital sleep treatment for teens with insomnia after hospitalization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-site, randomized pilot comparing a brief, six-session digital CBT for insomnia (Sleepio) plus post-hospitalization usual care to usual care alone in adolescents. Eighty participants aged 14–18 with clinically significant insomnia who were recently hospitalized for suicide risk will be enrolled across Rutgers (NJ) and Children's Hospital of The King's Daughters/Old Dominion University (VA). Participants assigned to Sleepio will complete six weekly ~20-minute sessions via smartphone or web while all participants continue standard post-discharge care; outcomes include feasibility, acceptability, insomnia symptom change, and measures of suicidal ideation and behavior during the high-risk post-discharge period. The study uses validated instruments (e.g., SCI, ISI, C-SSRS) and short-term follow-up to capture effects in the first weeks-to-months after discharge.

Why it matters

Who can join: the full rules

Inclusion:

1. Age 14-18 years old.
2. 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).
3. 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
4. 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:

1. Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
2. Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.
3. Substance use disorder that is primary to insomnia which would require alternative treatment.
4. 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).
5. Unwillingness to wear wrist actigraphy or complete the EMA surveys.
6. 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.
7. Having a sibling who has enrolled in the study.

Where it's running

• Rutgers University Behavioral Healthcare
  Piscataway, New Jersey, United States Recruiting
• Children's Hospital of The King's Daughters
  Norfolk, Virginia, United States Recruiting

Study contacts

• Principal investigator: Evan Kleiman — Rutgers
• Study coordinator: Evan Kleiman, PhD
• Email: evan.kleiman@rutgers.edu
• Phone: 848-445-2345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.