Sleep Treatment for Teens (RCT Phase)

Sleep Treatment for Teens

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicidal Behavior; Sleep Problems
• Intervention / Treatment: Behavioral: Treatment as Usual (TAU); Behavioral: Sleepio

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evan Kleiman, PhD; Phone Number: 848-445-2345; Email: evan.kleiman@rutgers.edu

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Recruiting
      • Rutgers University Behavioral Healthcare
      • Contact: Evan Kleiman; Phone Number: 2153596148; Email: evan.kleiman@rutgers.edu
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Children's Hospital of The King's Daughters
      • Contact: Catherine Glenn; Phone Number: (757) 683-4458; Email: cglenn@odu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual (TAU) + ecological momentary assessment (EMA); Treatment as usual plus assessments via EMA	Behavioral: Treatment as Usual (TAU); Treatment as usual as part of standard inpatient care, and any outpatient care received.
Experimental: Sleepio (TM) + Treatment as usual (TAU) + EMA; 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.; Behavioral: Sleepio; Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity	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).	Up to 12 weeks
Suicidal thoughts	Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	Sleep efficiency (SE), percent of time in bed spent asleep, assessed via Actiwatch.	Daily through study completion, up to 12 weeks
Sleep Onset Latency	Sleep onset latency (SOL): how many minutes it takes to fall asleep, assessed via Actiwatch device	Daily throughout the study (12 weeks)
Daily Suicidal Thoughts	Daily reports of suicide ideation from EMA	Daily through study completion, up to 12 weeks
Wake after sleep onset	Wake after sleep onset (WASO): total amount of time awake during the night, assessed via Actiwatch wearable.	Daily through study completion, up to 12 weeks
Subjective sleep quality	Sleep quality: subjective ratings on 1=very poor to 5=very good, assessed via ecological momentary assessment.	Daily through study completion, up to 12 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Mental Health (NIMH); Old Dominion University; Children's Hospital of The King's Daughters
• Investigators: Principal Investigator: Evan Kleiman, Rutgers

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Sleep Wake Disorders; Suicide; Behavior; Suicidal Ideation; Parasomnias; Therapeutics
• Other Study ID Numbers: Pro2021001233_mod 10; R34MH123590 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Via NIMH data archive
• IPD Sharing Time Frame: 1 year after the study ends
• IPD Sharing Access Criteria: Access to the NIMH data archive
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No