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Completed

NCT Number: NCT05275101

Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy

The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adults with current suicidal intent will be randomly assigned to receive either a 1-hour session of crisis response planning (CRP) or a 1-hour session of standard crisis risk management (Treatment as Usual). The effects of both conditions on changes in emotion regulation, behavioral inhibition, stress reactivity, and suicide risk will be evaluated post-intervention and at six-month follow-up. Additional assessments of changes in mood and suicidality will be collected daily during the first 10-days following intervention, and then monthly for a duration of six months. A cohort of healthy controls is included in the study but are not randomized to either treatment condition. The investigators hypothesize the following: 1) A single session of CRP will acutely change suicide risk and 2) Individuals who receive CRP will show sustained improvements in measures of suicidality when compared to individuals who received the Treatment as Usual intervention.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally medically and neurologically healthy
  • Age 18 years or older at the time of consent
  • Willing and able to give informed consent
  • Individuals in the acutely suicidal group: endorse current suicide intent as indicated by a total score of 5 or greater on the Beck's Scale for Suicidal Ideation.

Exclusion criteria

  • Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study
  • Current or past manic/hypomanic episode, schizophrenia, or psychotic symptoms
  • Deafness in either ear
  • Currently pregnant or trying to become pregnant
  • Electroconvulsive therapy (ECT) within the past 6 months
  • Current moderate to severe substance use disorder
  • Lack of fluency in English
  • Positive alcohol breathalyzer test and/or acute drug intoxication the day of the fMRI scans
  • Unwilling or unable to sign the informed consent document
  • Under 18 years old at the time of enrollment
  • Traumatic brain injury from a suicide attempt or another event
  • Presence of ferrous-containing metals within the body
  • Inability to tolerate small, enclosed spaces without significant anxiety
  • Individuals enrolled as controls: no lifetime history of any DSM-5 disorder
  • Individuals enrolled as controls: no lifetime history of suicide ideation or intent

Treatment and study plan

Crisis Response Planning

Behavioral

Individuals complete an experimental collaborative suicide intervention.

Crisis Risk Counseling

Behavioral

Individuals complete a standard crisis risk management intervention.

Primary outcomes

  1. Frontolimbic neural circuit activation and connectivity

    Time frame: Pre-treatment, Post-treatment, and 6-months follow-up.

    Task-induced activity in frontolimbic neural circuits measured with fMRI. Core regions of interest are: ventral prefrontal cortex, dorsal prefrontal cortex, inferior frontal gyrus, insula, and dorsal anterior cingulate cortex.

  2. Suicidality

    Time frame: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.

    Self-reported suicide ideation, intent, behaviors and urges will be repeatedly assessed throughout the protocol using the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R), Beck's Scale for Suicidal Ideation (SSI), Lethality Rating Scale, and Suicide Cognitions Scale - Revised (SCS-R).

Secondary outcomes

  1. Markers of negative affectivity

    Time frame: Pre-treatment, Post-treatment, and 6-months follow-up.

    Acoustic startle electromyographic (EMG) response, behavioral data (i.e., reaction times and self-report scales) during lab tasks.

  2. Mood and psychiatric symptoms

    Time frame: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.

    Mood states and general depression and anxiety symptoms are repeatedly assessed throughout the protocol using the Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI), Beck Hopelessness Scale, Snaith-Hamilton Pleasure Scale (SHAPS), UPPS-P Impulsive Behavior Scale, and Validated Visual Mood Analog Scales (VMAS).

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2022
Registry last updated
Apr 30, 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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