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

NCT05275101 | Completed

• 1 other identifier: 2021H0039
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide

Keywords

Suicide Prevention; Crisis Response Planning; Suicide; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Markers of negative affectivity

  Pre-treatment, Post-treatment, and 6-months follow-up.

• Mood and psychiatric symptoms

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

Study Arms (3)

Control

NO INTERVENTION

Individuals who have not experienced suicidal ideation will not complete a suicide intervention.

Crisis Response Planning (CRP)

EXPERIMENTAL

The crisis response planning (CRP) session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. The CRP session involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the patient to share the events, symptoms, and contextual factors leading up to and surrounding the participant's suicidal crisis. Next, the patient and therapist identify the patient's personal warning signs for an emotional crisis, self-management coping skills, patient's reasons for living, and sources of social support. These components are written, by the patient, on an index card. The index card serves as a concrete reference for patients in the real-world.

Behavioral: Crisis Response Planning

Crisis Risk Counseling

ACTIVE COMPARATOR

The crisis risk counseling session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which subjects will complete a self-guided safety plan worksheet. The worksheet takes approximately 10-minutes to complete and will be done independently.

Behavioral: Crisis Risk Counseling

Interventions

Crisis Response Planning BEHAVIORAL

Individuals complete an experimental collaborative suicide intervention.

Crisis Response Planning (CRP)

Crisis Risk Counseling BEHAVIORAL

Individuals complete a standard crisis risk management intervention.

Crisis Risk Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Stephanie Gorka, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 11, 2022
• Study Start: July 28, 2021
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data, as outlined above, will be submitted to the NIMH Data Archive biannually per NIMH requirements throughout the duration of the study.

Locations

US (1)