Sleep Treatment for Teens
NCT05397353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-06-13
Summary
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.
Conditions
- Sleep Problem
- Suicidal Ideation
- Suicide, Attempted
Interventions
- OTHER
-
Sleepio (TM)
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Sponsors & Collaborators
-
Old Dominion University
collaborator OTHER -
Children's Hospital of The King's Daughters
collaborator OTHER -
Rutgers, The State University of New Jersey
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-10
- Primary Completion
- 2025-01-24
- Completion
- 2025-04-04
Countries
- United States
Study Locations
More Related Trials
-
i-Sleep: Internet-based Treatment for Insomnia
NCT03110263 ·Status: TERMINATED ·Phase: NA
-
Suvorexant and Trauma Related Insomnia
NCT02704754 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
NCT06953869 ·Status: RECRUITING ·Phase: PHASE3
-
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
NCT04932096 ·Status: COMPLETED ·Phase: PHASE2
-
Solriamfetol and CBT-I in Patients With Insomnia Disorder
NCT05838430 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
NCT00593736 ·Status: COMPLETED ·Phase: PHASE2
-
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
NCT02849548 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
NCT02578186 ·Status: COMPLETED ·Phase: PHASE4
-
The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)
NCT05922995 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Sleep Intervention
NCT03047356 ·Status: COMPLETED ·Phase: NA
-
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
NCT02776215 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia
NCT02043977 ·Status: COMPLETED ·Phase: PHASE1
-
The Treatment of Insomnia in Patients With HIV Disease
NCT00465972 ·Status: COMPLETED ·Phase: PHASE4
-
Melatonin Treatment for Induced Transient Insomnia
NCT00950885 ·Status: COMPLETED ·Phase: NA
-
Trial of Zolpidem for Sleep in Children With Autism
NCT05540574 ·Status: RECRUITING ·Phase: PHASE2
-
Oral Bedtime Melatonin in Critically Ill Patients
NCT06156059 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia
NCT02153788 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism
NCT01887132 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
NCT00318448 ·Status: COMPLETED ·Phase: PHASE3
-
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
NCT02818569 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
NCT00539110 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
NCT05372887 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
NCT05361707 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Assess Impact of Dietary Supplement on Sleep Health
NCT05971771 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
NCT06114901 ·Status: NOT_YET_RECRUITING ·Phase: NA