Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Completed · Not applicable
Conditions studied: Bipolar Disorder, Major Depressive Disorder, Mood Disorders, Suicide, Suicidal Ideation
In brief
The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.
Key facts
- Study ID
- NCT05317481
- Run by
- Yale University
- People needed
- 65
- Starts
- 2022-04-01
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2026-04-13
Who can join
Age: 16 and older, up to 29. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD)
- have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI
You may not qualify if…
- Significant medical or neurologic illness (especially if related to cerebral tissue)
- MRI contraindication,
- pregnancy by urine test
- current moderate or severe alcohol/other substance use disorders except caffeine/nicotine
- positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month
- current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest (e.g. transcranial magnetic stimulation or electro-convulsive therapy),
- current psychosis
- inability to provide informed consent, including IQ<70, Young Mania Rating Scale (YMRS) >25, or too symptomatic by PI's judgment
- active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician.
- homicidal ideation
Where it is running
- Magnetic Resonance Research Center — New Haven, Connecticut, United States
- Mood Disorders Research Program — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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