Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms and Improve Brain Circuitry Functioning

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    128
  • sponsor
    Yale University
Updated on 17 June 2022
bipolar disorder
depressive disorder
suicide

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 investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), a modification of Social Rhythm Therapy (SRT) 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.

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 research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions with a research therapist with the first, middle and last sessions in person, remaining sessions offered by secure video or audio telecommunication and 6-month in person follow-up.

Objectives

  1. Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases
  2. Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system)

Details
Condition Bipolar Disorder, Major Depressive Disorder, Mood Disorders, Suicide, Suicidal Ideation
Treatment BE-SMART-DR, psychoeducational control comparator condition (CC)
Clinical Study IdentifierNCT05317481
SponsorYale University
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

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