Sleepio (TM)
OtherSleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
NCT Number: NCT05397353
The purpose of this research study is to test 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=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
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Notify Me14 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 criteria
Exclusion criteria
Prior CBT-I treatment (the intervention being tested in this study): prior treatment would indicate non-response to a reasonable dose of this empirically supported treatment.
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Time frame: Baseline and end of study (up to 10 weeks after baseline).
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
Time frame: Baseline and end of study (up to 10 weeks after baseline).
Suicide Ideation Questionnaire Junior, a self-report measure of suicidal ideation. Total scores range from 0 to 90, with higher scores indicating greater suicidal ideation (worse outcome).
Rutgers, The State University of New Jersey
Other
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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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