This study is aimed to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution for reducing national suicide rates. The intervention, Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), a modification of Social Rhythm Therapy (SRT), provides self-directed strategies that can be used lifelong, regularizing sleep and other DRs to reduce short-term, and potentially long-term, suicide risk.
Sleep and other DR irregularities are robust risk factors for suicide thoughts and behaviors (STBs). Targeting them may have direct effects in reducing STBs, and indirect effects via multiple paths, as regularizing DRs has beneficial effects on psychiatric and other medical conditions that also increase suicide risk. Self-directed strategies to improve DR regularity in adolescence and young adulthood could reduce short-term, and potentially lifelong, suicide risk, as this is a critical period of development when brain systems that affect DRs are maturing, lifelong habits are established, and STBs often first emerge. While studies show negative effects of DR disruptions, research is scarce on interventions to improve DR regularity and thereby STBs and their underlying brain mechanisms. Multi-modal clinically relevant symptom, behavioral and functional magnetic resonance imaging (fMRI) measures, as planned in the proposed study, can elucidate psychological and biological mechanisms underlying development and prevention of STBs, improving early risk detection and generation of additional targeted preventive strategies.
The Principal Investigator and co-Investigators have long performed STB research and established the needed research, including safety, infrastructure. BE-SMART-DR has shown high adherence, acceptability and feasibility, facilitated by sessions provided via secure videoteleconferencing. It therefore has potential for widespread national dissemination, broad clinical implementation, and substantial impact on the goal to reduce the national suicide rate by 20% by 2025.
The 12-week BE-SMART-DR targets a hypothalamus-amygdala-ventral prefrontal cortex (HAV) brain system, that subserves brain functions important in STBs e.g. emotional and other behavioral control, and that has shown sensitivity to alterations in DRs. This proposal builds on our exciting preliminary data using BE-SMART-DR supporting reductions in STBs associated with improvements in DR regularity and HAV system functioning. In this study, clinical, behavioral and fMRI assessments will be performed in-person at first, middle and last sessions, and remaining sessions are remote by videotelecommunication. Suicidal ideation and propensity will be primary outcome measures. We plan study of 96 adolescents and young adults, ages 16-29 years, randomized 2:1 to BE-SMART-DR or a psychoeducation control comparator. In order to study subjects at high short-term suicide risk, with urgent need for prevention, they will have a mood disorder (bipolar or major depressive disorder), history of suicide attempt and ideation. Technological tools used will include digital actigraphy “watch†and ecological momentary assessment smartphone methods, implemented to perform real-time assessments of DRs, and multiple daily assessments of STBs and related symptoms and behaviors, to elucidate early indicators of suicide risk reductions and temporal patterns of changes. Re-assessments will be performed 6 months after completion of the intervention to follow-up on preliminary evidence that STB reductions with BE-SMART-DR are sustained over the subsequent 6 months.
