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| Name | Class |
|---|---|
| Old Dominion University | OTHER |
| Children's Hospital of The King's Daughters | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleepio | Experimental | Participants will receive the SleepioTM app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleepio (TM) | Other | Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
|
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University Behavioral Healthcare | Piscataway | New Jersey | 08854 | United States | ||
| Old Dominion University |
Data will be shared in accordance with NIMH Data Archive Agreement
1 year after the grant period is complete, which includes both this study and the companion RCT.
Registration on NIMH Data Archive
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2026 | Jun 9, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2022 | May 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| Norfolk |
| Virginia |
| 23529 |
| United States |
| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |