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Behavioral Intervention

DBT + CBT for Insomnia for Adolescents at High Risk of Suicide

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the dbt program.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to reduce teen suicide rates by testing if adding an evidence-based insomnia treatment to a suicide-focused therapy helps more than just the suicide-focused therapy alone.

Who is the study for?
This trial is for English-speaking teens aged 12-18 who are at high risk for suicide, have had a suicide attempt or multiple self-harm episodes, and suffer from insomnia. They must be on stable medication if they're taking any for psychiatric disorders or sleep issues, and live at home with a family member willing to participate.
What is being tested?
The study tests whether adding digital Cognitive Behavioral Therapy for Insomnia (CBT-I) to Dialectical Behavior Therapy (DBT) helps reduce suicidal thoughts and behaviors more effectively than DBT alone in adolescents. Participants will also wear a sleep-tracking device.
What are the potential side effects?
While not explicitly stated, side effects may include discomfort from discussing sensitive topics during therapy sessions, potential privacy concerns with wearing the sleep-tracking device, and possible emotional distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the dbt program.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the dbt program. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index (ISI)
Suicidal Ideation Questionnaire Junior (SIQ-JR)
Suicide Attempt Self-Injury Interview and Count

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for InsomniaExperimental Treatment2 Interventions
Group II: Dialectical Behavior Therapy OnlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1930
Dialectical Behavior Therapy
2016
Completed Phase 4
~960

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,921 Previous Clinical Trials
2,742,815 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,938 Total Patients Enrolled

Media Library

Dialectical Behavior Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05842863 — N/A
Suicide and Self-Harm Research Study Groups: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia, Dialectical Behavior Therapy Only
Suicide and Self-Harm Clinical Trial 2023: Dialectical Behavior Therapy Highlights & Side Effects. Trial Name: NCT05842863 — N/A
Dialectical Behavior Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842863 — N/A
~29 spots leftby May 2026
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