Recruiting

dCBT-I

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07303959

Conditions

Sleep Problems

Suicidal Ideation

Suicidal Behavior

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Sleepio

Treatment as Usual (TAU)

Study Details

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

Study ID

NCT07303959

Start date

Jun 2, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment as usual (TAU) + ecological momentary assessment (EMA)

Treatment as usual plus assessments via EMA

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

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

Interventions

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.

Primary outcome measure

  • Insomnia severity [ Time Frame: Up to 12 weeks ]
  • Suicidal thoughts [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Rutgers University Behavioral Healthcare

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-10.