N/A
N=65
Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Bipolar Disorder · Major Depressive Disorder · Mood Disorders · Suicide · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT05317481 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity — 12.83; 12.41; 10.84; 12.76 score on a scale — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BE-SMART-DR (Behavioral); psychoeducational control comparator condition (CC) (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity |
12.83; 12.41; 10.84; 12.76; 9.20; 10.29 | 0.0008 sig |
| PRIMARY Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation. |
17.1; 18.76; 3.97; 4.59; 1.13; 3.06 | <.0001 sig |
| PRIMARY Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS) |
33.63; 33.24; 30.11; 34.18; 27.57; 35.35 | 0.0002 sig |
| PRIMARY Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI) |
7.53; 7.94; 7.25; 8.18; 6.27; 7.65 | 0.0486 sig |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05317481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.