Sleep Treatment for Teens (RCT Phase)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleepio, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Sleep Problems, Suicidal Ideation, Suicidal Behavior. Basic parameters: 14 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sleep Treatment for Teens
Overview
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.
Interventions
- Behavioral Sleepio
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.
Primary outcome measures
- Insomnia severity [Time frame: Up to 12 weeks]
- Suicidal thoughts [Time frame: Up to 12 weeks]
Secondary outcome measures (5)
- Sleep efficiency [Time frame: Daily through study completion, up to 12 weeks]
- Sleep Onset Latency [Time frame: Daily throughout the study (12 weeks)]
- Daily Suicidal Thoughts [Time frame: Daily through study completion, up to 12 weeks]
- Wake after sleep onset [Time frame: Daily through study completion, up to 12 weeks]
- Subjective sleep quality [Time frame: Daily through study completion, up to 12 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Rutgers University Behavioral Healthcare — Piscataway
- Children's Hospital of The King's Daughters — Norfolk
Identifiers
NCT: NCT07303959 · Pro2021001233_mod 10 · R34MH123590