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 range16 Years – 29 Years

SexALL

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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

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

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