Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-06-02
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment as usual (TAU) + ecological momentary assessment (EMA)
Treatment as usual plus assessments via EMA
Treatment as Usual (TAU)
Treatment as usual as part of standard inpatient care, and any outpatient care received.
Sleepio (TM) + Treatment as usual (TAU) + EMA
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Sleepio
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Treatment as Usual (TAU)
Treatment as usual as part of standard inpatient care, and any outpatient care received.
Interventions
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Sleepio
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Treatment as Usual (TAU)
Treatment as usual as part of standard inpatient care, and any outpatient care received.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
14 Years
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Old Dominion University
OTHER
Children's Hospital of The King's Daughters
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Evan M. Kleiman, Ph.D.
Associate Professor
Principal Investigators
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Evan Kleiman
Role: PRINCIPAL_INVESTIGATOR
Rutgers
Locations
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Rutgers University Behavioral Healthcare
Piscataway, New Jersey, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Evan Kleiman
Role: primary
Catherine Glenn
Role: primary
Provided Documents
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Document Type: Informed Consent Form: new
Other Identifiers
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Pro2021001233_mod 10
Identifier Type: -
Identifier Source: org_study_id