Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms and Improve Brain Circuitry Functioning
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- STATUS
- Recruiting
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- End date
- Mar 31, 2025
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- participants needed
- 128
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- sponsor
- Yale University
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
- Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases
- 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 Identifier | NCT05317481 |
| Sponsor | Yale University |
| Last Modified on | 17 June 2022 |
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