Suicide Specific Rumination in Veterans

NCT06481033 | Recruiting DMC

• 1 other identifier: D5132-P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Suicide; Mood Disorders

Outcome Measures

Primary Outcomes (1)

• Acceptability and Feasibility

  The Client Satisfaction Questionnaire will be used to assess acceptability and feasibility of implementing real-time fMRI neurofeedback in a Veteran population. The total score on the questionnaire ranges from from 8 to 32 with higher scores indicative of greater satisfaction.

  Total score obtained 2 weeks following first real-time fMRI neurofeedback session.

Secondary Outcomes (1)

• Suicide Rumination Scale

  Change in total score from pre-treatment to post-treatment (2 weeks).

Study Arms (1)

Real-time fMRI Neurofeedback

EXPERIMENTAL

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.

Behavioral: Real Time fMRI Neurofeedback

Interventions

Real Time fMRI Neurofeedback 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.

Real-time fMRI Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

MeSH Terms

Conditions

Depression; Suicide; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior; Mental Disorders

Study Officials

• Philip R Szeszko, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip R Szeszko, PhD

CONTACT

(718) 584-9000; Philip.Szeszko@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The goal of this study is to collect feasibility and acceptability data regarding the utility of using real-time functional magnetic resonance imaging neurofeedback in veterans experiencing suicide-specific rumination defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." Veterans will be provided neurofeedback signals from the brain to identify mental strategies for altering brain connectivity to reduce rumination. Pre- and post-treatment assessments of suicide, disability, functional impairment, and quality of life will be collected.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be shared with scientific collaborators after the data have been analyzed and submitted for publication.
• Access Criteria: De-identified data will be shared when the study is completed and following IRB approval.

Locations

US (1)