NCT05317481Completed
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 23 Mar 2022
- Start date
- Apr 2022
- Primary completion date
- Mar 2025
- Lead sponsor
- Yale University
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT05317481
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From Apr 2022 to the primary completion date, Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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),
Other illness
- Significant medical or neurologic illness (especially if related to cerebral tissue)
- current moderate or severe alcohol/other substance use disorders except caffeine/nicotine
Other
- MRI contraindication,
- pregnancy by urine test
- 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 psychosis
- inability to provide informed consent, including IQ\<70, Young Mania Rating Scale (YMRS) \>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
Who the study is looking for
- 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
Age in the registry: 16 years to 29 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mood Disorders Research Program Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Magnetic Resonance Research Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.