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NCT Number: NCT06481033

Suicide Specific Rumination in Veterans

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James J. Peters VA Medical Center, Bronx, NY

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

Location status: Recruiting

Location contact

Philip R Szeszko, PhD

CONTACT

[email protected]

718-584-9000 ext. 5869

Philip R Szeszko, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability and Feasibility

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

    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.

Secondary outcomes

  1. Suicide Rumination Scale

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

    The Suicide Rumination Scale is a self-report inventory designed to quantify the extent to which an individual ruminates about suicide. The total score on the scale ranges from 0 to 32 with higher scores indicative of greater rumination.

Study contacts

Contact information is provided by the study sponsor or research team.

Philip R Szeszko, PhD

CONTACT

[email protected]

(718) 584-9000 ext. 5869

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Reducing Suicide-Specific Rumination in Veterans Using Real-time Functional Magnetic Resonance Imaging Neurofeedback

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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