Trial results for Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), an intervention aimed at reducing suicide risk in adolescents and young adults, were posted on ClinicalTrials.gov on 2026-04-13. The study enrolled 65 participants with conditions including Bipolar Disorder, Major Depressive Disorder, Mood Disorders, Suicide, and Suicidal Ideation.
Background
Suicide risk, particularly among adolescents and young adults, remains a significant public health concern. Mood disorders like Bipolar Disorder and Major Depressive Disorder are often associated with suicidal ideation. Interventions that can provide self-directed strategies to reduce short-term and potentially long-term suicide risk are highly sought after. This study investigated BE-SMART-DR, a non-pharmacologic psychobehavioral intervention designed to regularize sleep and other daily rhythms.
Trial design
This completed study, designated as Phase NA, enrolled 65 participants. The trial focused on individuals with Bipolar Disorder, Major Depressive Disorder, Mood Disorders, Suicide, and Suicidal Ideation. The intervention, Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), provided self-directed strategies to regularize sleep and other daily rhythms. It was compared against a Control Comparator Condition.
Key results
The study assessed suicidal ideation and propensity using two scales:
- Concise Health Risk Tracking Scale-Self Reported (CHRT-SR):
- For the BE-SMART-DR group, mean scores were 12.83 (Standard Error 1.08), then 10.84 (Standard Error 1.09), and finally 9.20 (Standard Error 1.08) score on a scale.
- For the Control Comparator Condition, mean scores were 12.41 (Standard Error 1.44), then 12.76 (Standard Error 1.44), and finally 10.29 (Standard Error 1.44) score on a scale.
- Beck Scale for Suicide Ideation (SSI):
- For the BE-SMART-DR group, mean scores were 17.1 (Standard Error 1.67), then 3.97 (Standard Error 1.30), and finally 1.13 (Standard Error 0.82) score on a scale.
- For the Control Comparator Condition, mean scores were 18.76 (Standard Error 2.22), then 4.59 (Standard Error 1.69), and finally 3.06 (Standard Error 1.08) score on a scale.
Key analyses using Mixed Models Analysis showed several significant within-group time effects:
- An F statistic of 7.78 with a p-value of 0.0008 for a within-group time effect.
- An F statistic of 2.38 with a p-value of 0.0985 for a within-group time effect.
- An F statistic of 37.43 with a p-value of 0.0001 for a within-group time effect.
- An F statistic of 20.83 with a p-value of 0.0001 for a within-group time effect.
- An F statistic of 9.73 with a p-value of 0.0002 for a within-group time effect.
- An F statistic of 0.67 with a p-value of 0.515 for a within-group time effect.
What this means
The results indicate that participants receiving the BE-SMART-DR intervention generally experienced a reduction in suicidal ideation scores over the course of the study. For the Concise Health Risk Tracking Scale-Self Reported (CHRT-SR), the BE-SMART-DR group's mean score decreased from 12.83 to 9.20, while the control group's score decreased from 12.41 to 10.29. More notably, on the Beck Scale for Suicide Ideation (SSI), the BE-SMART-DR group's mean score significantly decreased from 17.1 to 1.13, compared to the control group's decrease from 18.76 to 3.06. The statistical analyses confirm significant within-group changes over time, suggesting that the intervention may contribute to a reduction in suicidal ideation and propensity in adolescents and young adults with mood disorders.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05317481, titled "Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms", were posted on 2026-04-13 on clinicaltrials.gov.