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Cognitive Behavioral Therapy

Digital Insomnia Treatment for Teen Sleep Disorders

N/A
Recruiting
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 14-18 years old (assessed via review of unit census)
Recent psychiatric hospitalization due to suicide risk within three months of discharge from the hospital
Must not have
Unwillingness to wear the actigraphy device or to complete smartphone-based EMA at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights

Summary

This trial is testing a new, six-session digital treatment for insomnia in adolescents who have recently been hospitalized for suicide risk. The trial will assess the feasibility, acceptability, and effectiveness of the treatment.

Who is the study for?
This trial is for teens aged 14-18 who were recently hospitalized for suicide risk and are experiencing significant insomnia. They must be motivated to engage in sleep treatment and have a parent or guardian's consent if under legal age. Teens with prior CBT-I treatment, high risk of sleep apnea, bipolar disorder, primary substance use disorders, or factors limiting study participation are excluded.
What is being tested?
The trial tests SleepioTM, a digital cognitive behavioral therapy app designed to improve sleep among suicidal adolescents with insomnia. It involves six weekly sessions alongside usual post-hospitalization care. The effectiveness will be assessed before, during, after the treatment phase and at a 1-month follow-up.
What are the potential side effects?
As SleepioTM is a non-pharmacological intervention focusing on behavior modification through an app-based platform, it does not have direct side effects like medications do; however participants may experience changes in their sleeping patterns as they adjust to the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 18 years old.
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I was hospitalized for suicide risk within the last 3 months.
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I have been diagnosed with severe insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing to wear an activity tracker and use a smartphone app for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleeplessness
Suicidal thoughts
Secondary study objectives
Daily Suicidal Thoughts
Sleep problems

Trial Design

1Treatment groups
Experimental Treatment
Group I: SleepioExperimental Treatment1 Intervention
Participants will receive the SleepioTM app

Find a Location

Who is running the clinical trial?

Children's Hospital of The King's DaughtersOTHER
12 Previous Clinical Trials
1,959 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,362 Total Patients Enrolled
Old Dominion UniversityOTHER
21 Previous Clinical Trials
15,054 Total Patients Enrolled

Media Library

SleepioTM (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05397353 — N/A
Sleep Disorders Research Study Groups: Sleepio
Sleep Disorders Clinical Trial 2023: SleepioTM Highlights & Side Effects. Trial Name: NCT05397353 — N/A
SleepioTM (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397353 — N/A
~8 spots leftby Sep 2025
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