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Completed

NCT Number: NCT05317481

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

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magnetic Resonance Research Center, New Haven, Connecticut, United States

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About this study

This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.

Objectives

  • Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases
  • Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BE-SMART-DR

Behavioral

Therapy 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

psychoeducational control comparator condition (CC)

Behavioral

Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being

Primary outcomes

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

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

    CHRT-SR is a validated, self-reported measure with a propensity subscore (9 items) identifying risk factors.

    Each item is scored on a five-point Likert scale with responses ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"), thereby creating a total propensity score ranging from 0-36,with higher scores showing higher levels of suicidal propensity.

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

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

    Beck SSI is one of the most widely used measures to assess suicidal ideation. This nineteen item scale has scores ranging from 0 to 38, with higher values indicating a greater risk of suicide.

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

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

    BSRS is a measure of DR regularity for 10 activities that include social contexts. It uses a scale ranging from 1 (very regularly) to 6 (very irregularly). Total scores range from 10 to 60, with higher scores indicating greater irregularity.

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

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

    PSQI is a self reported questionnaire that assesses sleep quality over a 1 month period. It consists of seven component scores with each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21) with higher scores indicating worse sleep quality.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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