Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide

Running, not enrolling · Not applicable

Conditions studied: Suicide and Self-harm

In brief

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.

Key facts

Study ID

NCT05842863

Run by

Stanford University

People needed

44

Starts

2024-08-14

Expected to finish

2027-01-30

Last updated by the study team

2026-08-03

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 12-18 years of age and not yet graduated from high school.
• Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index .
• 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.).
• If taking medication for psychiatric disorders or sleep, must be on a stable dose (>2 months).
• Youth and parent both speak English.
• At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group.
• Youth lives at home.

You may not qualify if…

• 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.
• A history of being diagnosed with an Autism Spectrum Disorder.
• 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.
• Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications.
• Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders.
• Court-ordered to treatment.

Where it is running

• Michele Berk — Stanford, California, United States

Full record on ClinicalTrials.gov

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