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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleeplessness

Suicidal thoughts

Secondary outcome measures

Daily Suicidal Thoughts

Sleep problems

Trial Design

1Treatment groups

Experimental Treatment

Group I: SleepioExperimental Treatment1 Intervention

Participants will receive the SleepioTM app

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of The King's DaughtersOTHER

12 Previous Clinical Trials

1,905 Total Patients Enrolled

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,212 Total Patients Enrolled

Old Dominion UniversityOTHER

20 Previous Clinical Trials

15,024 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians welcome in this clinical trial?

"According to the eligibility requirements, the patients who can enroll in this 109th clinical trial are aged between 14 and 18. There are 264 clinical trials for people who are over 65."

Answered by AI

Are there any restrictions for who can and cannot sign up for this research opportunity?

"This clinical trial is looking for 20 participants between the ages of 14 and 18 who have suicidal ideation. Candidates must meet the following criteria: -Age 14-18 years old (assessed via review of unit census)-Recent psychiatric hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan): assessed using an abbreviated version of the Columbia Suicide Severity Rating Scale (C-SSRS). In terms of recency, adolescents will need to enroll in the baseline assessment within three months of discharge from the hospital"

Answered by AI

Are there still opportunities for participants in this experiment?

"The trial is currently recruiting patients, with the most recent update being on October 11th, 2022. The original posting date for the trial was October 1st, 2022."

Answered by AI

Could you provide an update on how many total individuals are taking part in this research?

"That is correct. The most recent information on clinicaltrials.gov suggests that this trial is still recruiting patients. This trial was first announced on October 1st, 2020 and was last updated on October 11th, 2020. The study is looking for 20 patients from 2 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Treatment for Teens

Evan M. Kleiman, Ph.D. 2023. "Sleep Treatment for Teens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397353.

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