80 Participants Needed

Sleepio for Suicidal Thoughts

Recruiting at 1 trial location
EK
Overseen ByEvan Kleiman, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital therapy app called Sleepio, designed to help teens with sleep problems who were recently hospitalized due to suicide risk. The researchers aim to determine if improving sleep through a smartphone or web-based program can reduce suicidal thoughts. Participants will either use the Sleepio app alongside their usual post-hospital care or receive only the usual care. Teens hospitalized for suicide risk and experiencing significant sleep problems might be suitable candidates, especially if they have access to a smartphone or are willing to use one. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance mental health care for teens.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that Sleepio is safe for adolescents with suicidal thoughts and insomnia?

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I), such as Sleepio, offers a promising way to improve sleep in teenagers. One study found that better sleep can reduce suicidal thoughts, suggesting that Sleepio, which addresses insomnia, might also help with these issues.

Regarding safety, users of dCBT-I generally find it manageable, with no reports of serious side effects. This is significant because Sleepio is accessible through a smartphone or web app, making it easy to use and minimizing risks.

Overall, evidence suggests that Sleepio is safe and could be beneficial for those dealing with both insomnia and suicidal thoughts.1234

Why are researchers excited about this trial?

Researchers are excited about Sleepio because it takes a fresh approach to addressing suicidal thoughts by targeting sleep issues through a digital platform. Unlike traditional treatments that often rely on medication or in-person therapy, Sleepio is a mobile Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) app, making it accessible and convenient. This app offers a personalized, evidence-based program that users can access anytime, potentially improving sleep patterns, which could have a positive impact on mental health and reduce suicidal thoughts. By addressing insomnia through digital means, Sleepio could provide a novel, scalable solution for those struggling with mental health issues related to sleep disturbances.

What evidence suggests that Sleepio might be an effective treatment for suicidal thoughts in adolescents with insomnia?

Research has shown that Sleepio, a digital therapy for insomnia, can help reduce suicidal thoughts. One study found that treating insomnia symptoms with this therapy led to fewer thoughts of suicide. Another study demonstrated that it improved sleep and lowered the risk of suicidal thoughts in people with insomnia. In this trial, participants will receive either Sleepio combined with treatment as usual and ecological momentary assessment (EMA) or treatment as usual with EMA alone. These findings suggest that addressing sleep problems in adolescents might reduce their risk of suicide. Overall, Sleepio's emphasis on better sleep appears to support mental health.56789

Who Is on the Research Team?

EK

Evan Kleiman

Principal Investigator

Rutgers

Are You a Good Fit for This Trial?

This trial is for teens aged 14-18 who have been hospitalized due to suicide risk and suffer from insomnia. They must be able to access a smart device compatible with the SleepioTM app, or they'll be provided one. Teens won't qualify if they don't meet these specific conditions.

Inclusion Criteria

I was recently hospitalized for suicide risk and discharged within the last 3 months.
I have significant insomnia symptoms.
I can access or am willing to use a smart device compatible with the study's requirements.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital cognitive behavioral therapy for insomnia (dCBT-I) through the Sleepio app, consisting of six weekly, 20-minute sessions, plus treatment as usual (TAU)

6 weeks
6 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of insomnia severity and suicidal thoughts

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Sleepio

Trial Overview

The study tests SleepioTM, a digital therapy app for insomnia, against usual care in suicidal adolescents post-hospitalization. It's a pilot trial at Rutgers and Old Dominion University involving six weekly sessions of dCBT-I (digital Cognitive Behavioral Therapy for Insomnia).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sleepio (TM) + Treatment as usual (TAU) + EMAExperimental Treatment2 Interventions
Group II: Treatment as usual (TAU) + ecological momentary assessment (EMA)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Old Dominion University

Collaborator

Trials
25
Recruited
15,500+

Children's Hospital of The King's Daughters

Collaborator

Trials
14
Recruited
12,000+

Citations

Cognitive-behavioral therapy for insomnia prevents and ...

Our trial showed that treating insomnia to remission with digital CBTI alleviates and prevents suicidal ideation. This study is the first to support treating ...

NCT05842863 | Combined Dialectical Behavior Therapy ...

The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in ...

Cognitive behavioral therapy for insomnia as a suicide ...

A recent meta-analysis reported a modest effect of sleep interventions in reducing suicidal ideation. However, these findings were limited by substantial ...

Sleep-specific outcomes attributable to digitally delivered ...

Conclusions. Digitally delivered CBT-I produced lasting improvements in sleep outcomes among adults with insomnia and depressive symptoms.

Suicidal Ideation Among Individuals With Insomnia ...

A digital cognitive behavioral therapy for insomnia was found to decrease risk for suicidal ideation among patients with insomnia.

Suicide Prevention | Washington State Department of Health

Call or text 988 or chat online to reach the 988 Suicide & Crisis Lifeline for support with a mental health crisis, substance use concerns, thoughts of ...

The effect and safety of sleep interventions on suicidal ...

Sleep disturbances are a risk factor for suicidal ideation, suicide attempts and suicide. While recent findings suggest that improving sleep by ...

Association Between Insufficient Sleep, Depressive ...

This study uses timely, representative, state-level data to examine the relationship between insufficient sleep, suicidal ideation, and depressive symptoms ...

Sleep Disturbance and Subsequent Suicidal Behaviors in ...

This cohort study examines parent- and child-reported types and severity of sleep disruptions and their association with suicidal ideation ...