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NCT05842863 · ClinicalTrials.gov registry record · NA
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
A NA study of Suicide and Self-harm, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT05842863: Recruiting NA study of Suicide and Self-harm, sponsored by Stanford University.
NCT05842863 is a NA study of Suicide and Self-harm that is actively recruiting participants, run by Stanford University. The registered enrollment target is 44 participants, below the 177-participant average among 11 other Suicide and Self-harm trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05842863, a NA study of Suicide and Self-harm, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The SIQ-JR (Reynolds 1987) is a 15-item self-report questionnaire that assesses suicidal thoughts on a 7-point scale (I never had this thought to almost every day). Scores range from 0 to 90, with a published clinical cut-off score of 31.
Conditions Studied
Interventions
- BEHAVIORAL Dialectical Behavior Therapy
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
Study Locations (1)
California
- Michele Berk - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT05842863 shows while recruiting
NCT05842863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 177-participant average among 11 other Suicide and Self-harm trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Suicide and Self-harm appearing as the primary indexed condition, and to 2 interventions - of which Dialectical Behavior Therapy is the first listed.
NCT05842863 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05842863 about?
NCT05842863 is a clinical study titled "Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide". 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 e...
What is the current status of trial NCT05842863?
This trial is currently recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2024-08-14. Estimated completion is 2026-06-30.
What conditions does trial NCT05842863 study?
This clinical trial studies the following conditions: Suicide and Self-harm.
What interventions are being tested in trial NCT05842863?
The interventions under investigation include: Dialectical Behavior Therapy (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT05842863?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05842863 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05842863's enrollment target sits among peer trials
44 8th of 11 higher than 4 of 11 other Suicide and Self-harm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicide and Self-harm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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