Status:
COMPLETED
Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Foundation for Suicide Prevention
Conditions:
Bipolar Disorder
Major Depressive Disorder
Eligibility:
All Genders
16-29 years
Phase:
NA
Brief Summary
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 investig...
Detailed Description
This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05317481
Start Date
April 1 2022
End Date
March 31 2025
Last Update
September 23 2025
Active Locations (2)
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1
Magnetic Resonance Research Center
New Haven, Connecticut, United States, 06510
2
Mood Disorders Research Program
New Haven, Connecticut, United States, 06510