Suicide Specific Rumination in Veterans

NCT ID: NCT06481033

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-12-31

Brief Summary

Few treatments target core features of suicidal thoughts and behaviors in Veterans. Real-time functional magnetic resonance imaging neurofeedback can provide information regarding brain activation associated with suicide-specific rumination, defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." The goal of this feasibility study is for Veterans to learn strategies for modulating activity within brain regions that have been demonstrated to contribute to the maintenance of rumination, as they receive neurofeedback feedback signals from the brain.

Detailed Description

Suicide is much higher in Veterans compared to non-Veterans and thus remains a major health crisis in the VA, but there are few treatments available that directly target core features of suicidal thoughts and behaviors. Rumination is the strong tendency to engage in self-critical repetitive thinking that is often difficult to interrupt and is associated with suicide attempts and the transition from suicidal ideation to intent above and beyond other suicide risk factors. Meta-analyses indicate that abnormalities in brain regions comprising the "default mode network," which play a role in daydreaming or mind-wandering, contribute to the maintenance of rumination. Although functional magnetic resonance imaging studies have provided key insights into the neurobiology of suicide, there has been little direct impact on clinical care thus far. With the advent of real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback, however, there is now the potential to implement personalized strategies for altering brain activity associated with rumination to reduce suicidal thoughts and behaviors. In the proposed study the investigators will determine the acceptability and feasibility of using rt-fMRI neurofeedback to reduce suicide-specific rumination, defined as "repetitive mental fixation on one's suicidal thoughts and intentions" in a transdiagnostic sample of 15 Veterans at elevated risk of suicide. The investigators will also assess pre- to post-treatment changes in measures of suicide-specific rumination, disability, functional impairment, and quality of life in Veterans with a suicide attempt history following 2 rt-fMRI neurofeedback sessions. Veterans will be provided signals from the brain to identify mental strategies (e.g., cognitive reappraisal) for altering brain connectivity. During a subsequent "transfer" period Veterans will be asked to utilize the mental strategy that worked best for altering this connectivity, but without receiving any neurofeedback signals from the brain. Post-treatment clinical assessments will occur following each of the 2 rt-fMRI neurofeedback sessions and at 1 month following the second fMRI neurofeedback session. The novelty of the proposed work is underscored by the paucity of work using rt-fMRI neurofeedback in a Veteran population and the lack of studies to date targeting a brain network to reduce suicide-specific rumination. In this study the investigators will test the following specific aims: (1) to determine the acceptability and feasibility of implementing rt-fMRI neurofeedback in a Veteran population experiencing suicide-specific rumination; (2) to identify changes in suicide-specific rumination following rt-fMRI neurofeedback and (3) to identify changes in functional impairment and quality of life following rt-fMRI neurofeedback. The proposed study is consistent with the mission of RR&D to maximize Veterans' functional independence, quality of life and participation in their lives and community.

Conditions

Depression; Suicide; Mood Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Real-time fMRI Neurofeedback

This is a pilot study to collect feasibility and acceptability data regarding the utility of real-time functional magnetic resonance imaging feedback for veterans experiencing suicide-specific rumination. All study participants will receive the intervention.

Group Type: EXPERIMENTAL

Real Time fMRI Neurofeedback

Intervention Type: BEHAVIORAL

The proposed pilot study is designed to collect feasibility and acceptability data regarding the utility of real-time functional magnetic resonance imaging (rt-fMRI) feedback in reducing suicide-specific rumination in veterans. Fifteen veterans will receive 2 rt-fMRI neurofeedback sessions while attempting to alter connectivity in brain regions that play a role in rumination. Pre- and post-treatment assessments of suicide, disability, functional impairment, and quality of life will be collected.

Interventions

Real Time fMRI Neurofeedback

The proposed pilot study is designed to collect feasibility and acceptability data regarding the utility of real-time functional magnetic resonance imaging (rt-fMRI) feedback in reducing suicide-specific rumination in veterans. Fifteen veterans will receive 2 rt-fMRI neurofeedback sessions while attempting to alter connectivity in brain regions that play a role in rumination. Pre- and post-treatment assessments of suicide, disability, functional impairment, and quality of life will be collected.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• U.S. military veteran between 18-65 years old
• negative pregnancy test on MRI scan days
• score greater than or equal to 10 on the Suicide Rumination Scale
• clinically stabilized on psychotropic medications
• engaged in mental health care treatment
• able to provide written, informed consent

Exclusion Criteria

• no major medical or neurological disorders that could interfere with treatment
• moderate or severe traumatic brain injury
• current imminent suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the assessor
• any current psychotic disorder
• MRI contraindications
• any substance use disorder for substances other than cannabis or alcohol (mild alcohol or cannabis use disorder does not exclude participants but moderate or severe alcohol or cannabis substance use disorder is disqualifying)
• pregnant or trying to become pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip R Szeszko, PhD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Philip R Szeszko, PhD

Role: CONTACT

Philip.Szeszko@va.gov

(718) 584-9000 ext. 5869

Facility Contacts

Philip R Szeszko, PhD

Role: primary

Philip.Szeszko@va.gov

718-584-9000 ext. 5869

Other Identifiers

D5132-P

Identifier Type: -

Identifier Source: org_study_id