NCT05884476

Brief Summary

Suicide prevention is a top priority for VA as all continue to seek new and inventive ways to reduce suicide rates among Veterans. Many experts agree that suicide prevention efforts could be improved by making suicide-specific interventions easier to access. The current project aims to move toward that goal by testing a web-based suicide prevention intervention using an experimental design. The roughly 40-minute intervention aims to teach Veterans coping skills that are designed to ease the emotional distress that often comes with thoughts of suicide. The project will evaluate whether Veterans who receive this intervention report more improvement in suicidal thoughts and behaviors than Veterans who receive a standard course of health care visits. Suicidal thoughts and behaviors will be measured over the course of one month. The investigators hypothesize that Veterans who receive the intervention will report lower suicidal thoughts and behaviors than those who receive the standard course of health care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2024Jun 2027

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

May 22, 2023

Last Update Submit

December 10, 2025

Conditions

Keywords

Suicidal IdeationSuicide, Attempted

Outcome Measures

Primary Outcomes (3)

  • Suicidal ideation severity change

    Data sourced from Beck Scale for Suicidal Ideation (BSS) self-report measure total score. BSS scores range from 0-38 on 19 items rated on a 0-2 scale. Higher scores indicate greater suicidal ideation severity.

    Baseline and one month

  • Psychological inflexibility of suicidal ideation change

    Data sourced from Acceptance and Action Questionnaire for Suicidal Ideation (AAQ-SI) self-report measure total scores. AAQ-SI scores range from 4-28 on seven items rated on a 1-7 scale. Higher scores indicate greater experiential avoidance of suicidal ideation.

    Baseline and two weeks

  • Suicidal behaviors change

    Data sourced from the Columbia Suicide Severity Rating Scale clinical interview (C-SSRS). The presence or absence of five categories of suicidal behaviors is indicated on a dichotomous (Yes/No) scale. Categories include: (1) Preparatory acts or behavior, (2) aborted attempt, (3) interrupted attempt, (4) actual attempt (non-fatal), and (5) completed suicide. Higher assigned score indicates greater severity of suicidal behavior.

    Baseline and one month

Study Arms (2)

REST + TAU

EXPERIMENTAL

Veterans in this condition will complete the REST intervention and be expected to remain engaged in their standard course of health care as described in the TAU condition.

Behavioral: Re-Evaluating Suicidal Thoughts

TAU

OTHER

Veterans in this condition will be expected to engage in their standard course of heath care.

Other: Treatment-as-usual

Interventions

Veterans in the TAU-only control condition will remain engaged in their normal standard of mental health care throughout their participation in this study. Veterans in the TAU condition will have access to and receive referrals for any of the following services normally afforded to patients at this VA hospital: VA Office of Connected Care web-based training programs and mobile mental health applications; primary care appointments; PCMHI consultation; outpatient mental health individual and group therapies; psychiatry appointments; inpatient hospitalization in the event of a suicidal crisis during study participation; and post-discharge mental health follow-up appointments following inpatient hospitalization for medical or mental health reasons.

Also known as: TAU
TAU

REST is a brief, computerized intervention designed to mitigate psychological inflexibility associated with the experience of suicidal ideation. Most individuals complete the intervention in under one hour. REST provides psychoeducation to correct common misconceptions about suicidal ideation and help Veterans de-catastrophize the occurrence and meaning of these thoughts. This includes information about the prevalence of suicidal ideation among Veterans, a conceptualization of suicidal ideation as a response to stress, normalizing emotional reactions to suicidal ideation, and framing suicidal ideation as "thoughts and conjectures" as opposed to "truth and reality." These components were chosen to directly address emotional distress related to suicidal thoughts, which is central to the construct of psychological inflexibility. Veterans randomized to receive REST will have access to and be encouraged to utilize any and all of these options described in the TAU-only condition.

Also known as: REST + TAU
REST + TAU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • years or older
  • Past two-week suicidal ideation as indicated by positive reply to C-SSRS questions ("Have you had any actual thoughts of killing yourself," or, "Have you been thinking about how you might do this?")

You may not qualify if:

  • Active psychosis
  • Unmedicated bipolar disorder
  • Instances in which a substance use disorder would indicate inpatient detoxification prior to engaging in other outpatient mental health interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

RECRUITING

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Joseph W Boffa, PhD

    Southeast Louisiana Veterans Health Care System, New Orleans, LA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph W Boffa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are blind to condition randomization, as is the PI, who provides suicide risk assessments throughout the follow-up period.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized (1:1) upon enrollment to one of two conditions.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

January 8, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There are no plans to disclose data outside of the VA, however, if there is a need to disclose data outside of the VA (e.g., a member of the scientific community requests a copy), IRB approval will be sought, data will be de-identified prior to disclosing, and the disclosure will be recorded on a VA disclosure log as required by VA policy.

Locations