NCT05317481

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 16 Years – 29 Years
• Healthy volunteers: Not accepted

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), 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.

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 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 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)

Conditions

• Bipolar Disorder
• Major Depressive Disorder
• Mood Disorders
• Suicide
• Suicidal Ideation

Interventions

Type	Name	Description
BEHAVIORAL	BE-SMART-DR	Therapy 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
BEHAVIORAL	psychoeducational control comparator condition (CC)	Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2022-04-07
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

2 sites across 1 country: United States