Clinical trial NCT05275101: Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
Official title: Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Suicide Prevention
Crisis Response Planning
Suicide
functional magnetic resonance imaging
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frontolimbic neural circuit activation and connectivity
timeFrame: Pre-treatment, Post-treatment, and 6-months follow-up.
measure: Suicidality
timeFrame: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
Secondary outcomes:
measure: Markers of negative affectivity
timeFrame: Pre-treatment, Post-treatment, and 6-months follow-up.
measure: Mood and psychiatric symptoms
timeFrame: Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Stephanie Gorka, PhD
role: PRINCIPAL_INVESTIGATOR
References: