Back to resultsNeural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crisis Response Planning
Crisis Risk Counseling
Sponsored by
About this trial
This is an interventional basic science trial for Suicide focused on measuring Suicide Prevention, Crisis Response Planning, Suicide, functional magnetic resonance imaging
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
Sites / Locations
- The Ohio State UniveristyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Control
Crisis Response Planning (CRP)
Crisis Risk Counseling
Arm Description
Individuals who have not experienced suicidal ideation will not complete a suicide intervention.
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.
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.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Markers of negative affectivity
Acoustic startle electromyographic (EMG) response, behavioral data (i.e., reaction times and self-report scales) during lab tasks.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05275101
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Prevention, Crisis Response Planning, Suicide, functional magnetic resonance imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals who have not experienced suicidal ideation will not complete a suicide intervention.
Arm Title
Crisis Response Planning (CRP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Crisis Risk Counseling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Response Planning
Intervention Description
Individuals complete an experimental collaborative suicide intervention.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Risk Counseling
Intervention Description
Individuals complete a standard crisis risk management intervention.
Primary Outcome Measure Information:
Title
Frontolimbic neural circuit activation and connectivity
Description
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.
Time Frame
Pre-treatment, Post-treatment, and 6-months follow-up.
Title
Suicidality
Description
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).
Time Frame
Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
Secondary Outcome Measure Information:
Title
Markers of negative affectivity
Description
Acoustic startle electromyographic (EMG) response, behavioral data (i.e., reaction times and self-report scales) during lab tasks.
Time Frame
Pre-treatment, Post-treatment, and 6-months follow-up.
Title
Mood and psychiatric symptoms
Description
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).
Time Frame
Pre-treatment, Post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Gorka, PhD
Phone
614-366-1027
Email
stephanie.gorka@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Gorka, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State Univeristy
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Gorka, PhD
Phone
614-366-1027
Email
stephanie.gorka@osumc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data, including fMRI, startle eyeblink, and behavior, from this project will be submitted to the NIMH Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NIMH Data Archive Data Sharing Terms and Conditions.
We will follow the two-tier procedure described in the guidelines:
Raw continuous fMRI recordings will be submitted in standard formats (Matlab mat format, DICOM format and NIFTI format). Experimental condition information will be supplied in text format along with other critical information.
Analyzed data (BOLD data, BOLD-startle eyeblink data) associated with a manuscript will be shared as soon as possible, and at the latest, at the time of publication of the manuscript. These data may be accompanied, if applicable, by other data such as behavioral data, supplied in text format.
IPD Sharing 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.
IPD Sharing URL
https://nda.nih.gov/
Learn more about this trial
Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
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