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DepressionNCT06481033

Suicide Specific Rumination in Veterans

A study testing Real Time fMRI Neurofeedback in people with Depression and Suicide, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Suicide, Mood Disorders
What is being tested?
Real Time fMRI Neurofeedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Aug 2024to 7 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • U.S. military Veteran
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Real Time fMRI Neurofeedback
Medical subject headings
Depression, Suicide, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real Time fMRI NeurofeedbackBehavioural

    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.

Study groups in NCT06481033
Study groupRoleWhat they receive
Real-time fMRI NeurofeedbackExperimentalThis 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.
Receives: Behavioral: Real Time fMRI Neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Suicide Rumination Scale

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start1 Aug 2024
  3. Primary completion17 Mar 2026
  4. Study completion7 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481033
Sponsor's protocol ID
D5132-P
Status last verified
Aug 2026
First submitted
17 Jun 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will obtain IRB approval prior to sharing de-identified data.

Questions about this trial

What is this clinical trial studying?

A study testing Real Time fMRI Neurofeedback in people with Depression and Suicide, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability and Feasibility (time frame: Total score obtained 2 weeks following first real-time fMRI neurofeedback session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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