Sleep Treatment for Teens (RCT Phase)

Rutgers The State University of New Jersey

Status

Enrolling

Conditions

Suicidal Ideation

Suicidal Behavior

Sleep Problems

Treatments

Behavioral: Treatment as Usual (TAU)

Behavioral: Sleepio

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07303959

Pro2021001233_mod 10

R34MH123590 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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.

Adolescents will be excluded based on the following exclusion criteria:

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.