ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-28
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05275101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Generally medically and neurologically healthy
  2. * Age 18 years or older at the time of consent
  3. * Willing and able to give informed consent
  4. * 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.
  1. * Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study
  2. * Current or past manic/hypomanic episode, schizophrenia, or psychotic symptoms
  3. * Deafness in either ear
  4. * Currently pregnant or trying to become pregnant
  5. * Electroconvulsive therapy (ECT) within the past 6 months
  6. * Current moderate to severe substance use disorder
  7. * Lack of fluency in English
  8. * Positive alcohol breathalyzer test and/or acute drug intoxication the day of the fMRI scans
  9. * Unwilling or unable to sign the informed consent document
  10. * Under 18 years old at the time of enrollment
  11. * Traumatic brain injury from a suicide attempt or another event
  12. * Presence of ferrous-containing metals within the body
  13. * Inability to tolerate small, enclosed spaces without significant anxiety
  14. * Individuals enrolled as controls: no lifetime history of any DSM-5 disorder
  15. * Individuals enrolled as controls: no lifetime history of suicide ideation or intent

Contacts and Locations

Principal Investigator

Stephanie Gorka, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Stephanie Gorka, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Suicide