Sleep Treatment for Teens (RCT Phase)

NCT07303959 | Recruiting DMC

• 2 other identifiers: Pro2021001233_mod 10R34MH123590
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sleep Problems; Suicidal Ideation; Suicidal Behavior

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Sleep efficiency

  Daily through study completion, up to 12 weeks

• Sleep Onset Latency

  Daily throughout the study (12 weeks)

• Daily Suicidal Thoughts

  Daily through study completion, up to 12 weeks

• Wake after sleep onset

  Daily through study completion, up to 12 weeks

• Subjective sleep quality

  Daily through study completion, up to 12 weeks

Study Arms (2)

Treatment as usual (TAU) + ecological momentary assessment (EMA)

ACTIVE COMPARATOR

Treatment as usual plus assessments via EMA

Behavioral: Treatment as Usual (TAU)

Sleepio (TM) + Treatment as usual (TAU) + EMA

EXPERIMENTAL

Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

Behavioral: Sleepio; Behavioral: Treatment as Usual (TAU)

Interventions

Sleepio BEHAVIORAL

Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

Sleepio (TM) + Treatment as usual (TAU) + EMA

Treatment as Usual (TAU) BEHAVIORAL

Treatment as usual as part of standard inpatient care, and any outpatient care received.

Sleepio (TM) + Treatment as usual (TAU) + EMA; Treatment as usual (TAU) + ecological momentary assessment (EMA)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator
• Old Dominion University: collaborator
• Children's Hospital of The King's Daughters: collaborator

Study Sites (2)

Rutgers University Behavioral Healthcare

Piscataway, New Jersey, 08854, United States

RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Evan Kleiman

  Rutgers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan Kleiman, PhD

CONTACT

848-445-2345; evan.kleiman@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: December 26, 2025
• Study Start: June 2, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after the study ends
• Access Criteria: Access to the NIMH data archive

Locations

US (2)