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New treatment option for Suicide and Self-harm
Official title Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
ClinicalTrials.gov ID: NCT05842863
What this study is testing
- What it's testing
- 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]).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18. Healthy volunteers may be eligible.
You may be able to join 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...
- If taking medication for psychiatric disorders or sleep, must be on a stable dose (\>2 months).
- Youth and parent both speak English.
You likely can't join if
- Significant current mania or psychosis; life threatening anorexia, or other diagnosis of a severe mental or physical condition requiring 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.
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.