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Can better sleep help prevent teen suicide? new trial tests combo therapy

NCT ID NCT05842863

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This pilot study tests whether adding a digital insomnia treatment (CBT-I) to standard suicide-focused therapy (DBT) helps reduce suicidal thoughts and self-harm in teens aged 12-18 who are at high risk for suicide. Forty-four participants will be randomly assigned to receive either DBT alone or DBT plus CBT-I for six months, with regular assessments of suicidal ideation, self-harm, and sleep. The goal is to see if improving sleep can boost the effectiveness of suicide prevention therapy.

What this could mean

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

Active substance
Dialectical Behavior Therapy (DBT) and digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If it works, this could point toward a more effective way to reduce suicide risk in teens by also treating their sleep problems.
What could go wrong
This is a very small pilot study (44 teens) testing feasibility, not a proven treatment. The added sleep therapy may not provide extra benefit over DBT alone.

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

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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

12 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. 12-18 years of age and not yet graduated from high school. 2. Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index . 3. High suicide risk, defined as: \> 3 lifetime self-harm episodes (with at least 1 in the 12 weeks before baseline screening) and elevated suicidal ideation (≥31 on the SIQ-Jr.). 4. If taking medication for psychiatric disorders or sleep, must be on a stable dose (\>2 months). 5. Youth and parent both speak English. 6. At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group. 7. Youth lives at home. Exclusion Criteria: 1. Significant current mania or psychosis; life threatening anorexia, or other diagnosis of a severe mental or physical condition requiring treatment specific to that disorder and/or that interferes with participation in assessments or treatment. 2. A history of being diagnosed with an Autism Spectrum Disorder. 3. Has a comorbid untreated sleep apnea or a severe circadian sleep-wake disorder with a habitual bedtime after 3 AM or habitual rise time after 11 AM. 4. Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications. 5. Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders. 6. Court-ordered to treatment.

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Conditions

The condition(s) this trial relates to.

insomnia Self-Injurious Behavior Suicide

As listed by the trial registrant

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

Contacts and locations

Locations

  • Michele Berk

    Stanford, California, 94305, United States

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