CompletedNot Applicable

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

United States65 participantsStarted 2022-04-01

Plain-language 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.

Who can participate

Age range

16 Years – 29 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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\<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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity

Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)

Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation.

Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)

Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS)

Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)

Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Baseline (pre-intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)

Trial details

NCT IDNCT05317481

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2026-03-11

View on ClinicalTrials.gov More Bipolar Disorder trials