Sleepio (TM) for Suicidal Ideation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rutgers University Behavioral Healthcare, Piscataway, NJ
Suicidal Ideation+5 More
Sleepio (TM) - Other
Eligibility
< 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Suicidal Ideation
  • Sleep disorders and disturbances
  • Parasuicide

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: up to 10 weeks

Week 10
Daily Suicidal Thoughts
Sleep problems
up to 10 weeks
Insomnia severity
Suicidal thoughts

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Sleepio
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Sleepio (TM) · No Placebo Group · N/A

Sleepio
Other
Experimental Group · 1 Intervention: Sleepio (TM) · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 weeks
Closest Location: Rutgers University Behavioral Healthcare · Piscataway, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Suicidal Ideation
0 CompletedClinical Trials

Who is running the clinical trial?

Children's Hospital of The King's DaughtersOTHER
10 Previous Clinical Trials
1,734 Total Patients Enrolled
Old Dominion UniversityOTHER
17 Previous Clinical Trials
14,908 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,167 Total Patients Enrolled
1 Trials studying Suicidal Ideation
200 Patients Enrolled for Suicidal Ideation

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 14 and 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.