Can a sleep app help save teens from suicide?

NCT ID NCT05397353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests a smartphone app called Sleepio that teaches teens with insomnia how to sleep better using cognitive behavioral therapy. The participants are 14- to 18-year-olds who have recently been hospitalized for suicidal thoughts or attempts. The goal is to see if improving sleep can help reduce suicide risk in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sleepio (digital cognitive behavioral therapy for insomnia app)
What this could lead to
If effective, this digital sleep therapy could become a practical tool to help reduce suicide risk in teens by improving sleep.
What could go wrong
This is a small pilot study with only 12 participants, so results may not apply broadly. The app may not work for everyone, and the study does not guarantee long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Feb 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 in order to assess the high-risk post-hospitalization period. * Clinically significant insomnia symptoms: consistent with prior trials using the SleepioTM package, participants will be screened using the Sleep Condition Indicator (SCI)-an 8-item measure created by SleepioTM treatment developers to screen for DSM-5 insomnia disorder. The SCI assesses sleep duration, quality, and difficulties, and daytime impairment due to sleep problems; lower scores on the SCI indicate poorer sleep conditions and a cutoff of ≤16 indicates probable insomnia disorder, which will be the cutoff used for the current study. * Motivation to engage in sleep treatment: consistent with other trials testing SleepioTM, questions will be used to assess perception of sleep problem severity and desire to change. The scale includes (1) "At present, sleep is a big problem for me" and (2) "I want to change my sleep" rated on a scale 0=strongly disagree to 10=strongly agree. Each item must be rated ≥5, in line with prior trials. Given this is a digital intervention, this criterion will help ensure we recruit adolescents who are likely to engage with treatment. Importantly, we note that prior trials have not needed to exclude anyone based on this criterion, reflecting the idea that the majority of participants we encounter will be motivated to engage in this novel treatment. Exclusion Criteria: Prior CBT-I treatment (the intervention being tested in this study): prior treatment would indicate non-response to a reasonable dose of this empirically supported treatment. * At high risk for obstructive sleep apnea (OSA): The STOP-BANG sleep apnea screening questionnaire (modified for adolescents) will be used to screen adolescents at high risk for OSA, who will be referred for a non-study polysomnography screening. * Bipolar disorder: given concerns that certain components of CBT-I (i.e., sleep restriction) may be risky for this population. * Substance use disorder that is primary to insomnia: significant substance use (alcohol or drug) disorders would require alternative treatment. * Presence of factors that may reduce participant's ability to provide assent/consent or to complete the study procedures (e.g., non-English speaking, severe cognitive impairment, pervasive developmental disorder, acute psychosis, risk for other-directed violence). * Unwillingness to wear the actigraphy device or to complete smartphone-based EMA at the time of enrollment: consistent with the research team's prior studies, if participants are actively enrolled in the study and then decide that they no longer want to wear the wrist actigraphy device, we will give them the option to continue only the SleepioTM and smartphone-based EMA parts of the study. • Not having a parent/legal guardian willing to provide permission (if adolescent is a minor) or consent (for their own participation): although permission is only required for minors, parents will be included for all adolescents to keep study procedures consistent for all participants.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Insomnia disorder are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

insomnia Parasomnias sleep disorder Suicidal Ideation Suicide, Attempted

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Old Dominion University

    Norfolk, Virginia, 23529, United States

  • Rutgers University Behavioral Healthcare

    Piscataway, New Jersey, 08854, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.