Sleepio
BehavioralSleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
NCT Number: NCT07303959
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.
Interested in participating?
Request Info14 year–18 year
All sexes
Interventional
Not applicable
Rutgers University Behavioral Healthcare, Piscataway, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Adolescents will be excluded based on the following exclusion criteria:
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Treatment as usual as part of standard inpatient care, and any outpatient care received.
Time frame: Up to 12 weeks
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).
Time frame: Up to 12 weeks
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
Time frame: Daily through study completion, up to 12 weeks
Sleep efficiency (SE), percent of time in bed spent asleep, assessed via Actiwatch.
Time frame: Daily throughout the study (12 weeks)
Sleep onset latency (SOL): how many minutes it takes to fall asleep, assessed via Actiwatch device
Time frame: Daily through study completion, up to 12 weeks
Daily reports of suicide ideation from EMA
Time frame: Daily through study completion, up to 12 weeks
Wake after sleep onset (WASO): total amount of time awake during the night, assessed via Actiwatch wearable.
Time frame: Daily through study completion, up to 12 weeks
Sleep quality: subjective ratings on 1=very poor to 5=very good, assessed via ecological momentary assessment.
Contact information is provided by the study sponsor or research team.
Rutgers, The State University of New Jersey
Other
Sleep Treatment for Teens
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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