Can better sleep help prevent teen suicide? new trial tests combo therapy
NCT ID NCT05842863
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
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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
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Michele Berk
Stanford, California, 94305, United States
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Other studies related to the condition(s) this trial covers.
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