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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275101
• Other study ID #: 2021H0039
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: Stephanie Gorka, PhD
• Phone: 614-366-1027
• Email: stephanie.gorka[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: February 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Crisis Response Planning
Individuals complete an experimental collaborative suicide intervention.
• Crisis Risk Counseling
Individuals complete a standard crisis risk management intervention.

Locations

Country	Name	City	State
United States	The Ohio State Univeristy	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frontolimbic neural circuit activation and connectivity	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.	Pre-treatment, Post-treatment, and 6-months follow-up.
Primary	Suicidality	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).	Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
Secondary	Markers of negative affectivity	Acoustic startle electromyographic (EMG) response, behavioral data (i.e., reaction times and self-report scales) during lab tasks.	Pre-treatment, Post-treatment, and 6-months follow-up.
Secondary	Mood and psychiatric symptoms	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).	Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.