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Behavioral Intervention

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

N/A
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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

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

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
~1800
Dialectical Behavior Therapy
2016
Completed Phase 4
~820

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,006 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this clinical trial enrollment extend?

"To be considered for participation, individuals must have a history of suicidal ideation and self-harm behaviors while also falling within the age range of 12 to 18. The recruitment process is targeting approximately 44 people."

Answered by AI

Is the research group still accepting new participants?

"Sadly, clinicaltrials.gov reports that this particular trial is not actively recruiting at present. It was first posted on December 1st 2023 and the latest update happened in May of 2023. On a brighter note, 204 other trials are accepting patients currently."

Answered by AI

Is the age limit for this trial restricted to those above 35 years of age?

"Patients aged between 12 and 18 years old are eligible for enrolment in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Michele Berk 2023. "Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05842863.
~29 spots leftby May 2026
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