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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH123590 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual (TAU) + ecological momentary assessment (EMA) | Active Comparator | Treatment as usual plus assessments via EMA |
|
| Sleepio (TM) + Treatment as usual (TAU) + EMA | Experimental | Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleepio | Behavioral | Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia severity | 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). | Up to 12 weeks |
| Suicidal thoughts | Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | Sleep efficiency (SE), percent of time in bed spent asleep, assessed via Actiwatch. | Daily through study completion, up to 12 weeks |
| Sleep Onset Latency | Sleep onset latency (SOL): how many minutes it takes to fall asleep, assessed via Actiwatch device |
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Inclusion:
Adolescents will be excluded based on the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evan Kleiman, PhD | Contact | 848-445-2345 | evan.kleiman@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evan Kleiman | Rutgers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University Behavioral Healthcare | Recruiting | Piscataway | New Jersey | 08854 | United States |
Via NIMH data archive
1 year after the study ends
Access to the NIMH data archive
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: new | Apr 2, 2025 | Sep 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual (TAU) | Behavioral | Treatment as usual as part of standard inpatient care, and any outpatient care received. |
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| Daily throughout the study (12 weeks) |
| Daily Suicidal Thoughts | Daily reports of suicide ideation from EMA | Daily through study completion, up to 12 weeks |
| Wake after sleep onset | Wake after sleep onset (WASO): total amount of time awake during the night, assessed via Actiwatch wearable. | Daily through study completion, up to 12 weeks |
| Subjective sleep quality | Sleep quality: subjective ratings on 1=very poor to 5=very good, assessed via ecological momentary assessment. | Daily through study completion, up to 12 weeks |
| Children's Hospital of The King's Daughters | Recruiting | Norfolk | Virginia | 23507 | United States |
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| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |