Actively Recruiting
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Led by Stanford University · Updated on 2026-04-29
44
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The proposed research addresses the urgent need to reduce suicide rates among teens. This will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical Behavior Therapy, \[DBT\]) with an evidence-based treatment protocol for insomnia (a digital version of Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone. Participants will be randomly assigned to receive 6 months of DBT plus CBT-I or to DBT alone and will complete research assessments measuring suicidal ideation, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. Participants will also wear a device on their wrist (like a Fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.
CONDITIONS
Official Title
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 18 years and not yet graduated from high school
- Insomnia symptoms with a score of 8 or higher on the Insomnia Severity Index
- High suicide risk with more than 3 lifetime self-harm episodes and at least 1 episode in the past 12 weeks, plus elevated suicidal thoughts
- Stable dose of psychiatric or sleep medication for more than 2 months if currently taking any
- Youth and parent both speak English
- At least one family member or responsible adult agrees to participate in assessments and group therapy
- Youth lives at home
You will not qualify if you...
- Current serious mania, psychosis, life-threatening anorexia, or other severe condition interfering with participation
- History of Autism Spectrum Disorder diagnosis
- Untreated sleep apnea or severe circadian sleep disorder with bedtime after 3 AM or rise time after 11 AM
- Insomnia symptoms caused by substance use or withdrawal from psychoactive medications
- Conditions requiring caution with CBT-I, such as bipolar disorder or seizure disorders
- Court-ordered to treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Michele Berk
Stanford, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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