Public Messaging to Increase Treatment Seeking for Veterans at Risk for Suicide

October 8, 2025 updated by: VA Office of Research and Development

Public Messaging to Increase Treatment Seeking Among Veterans at Risk for Suicide During Transition From Military Service

The risk for suicide increases by nearly 50% in the first year that service members transition from the military to civilian life underscoring the need for effective strategies to facilitate help seeking among Veterans vulnerable to self-directed violence. Yet despite a great need for treatment, more than half of returning Veterans at risk for suicide do not initiate mental health services. VA has embarked on the regular use of communication campaigns as part of a public health approach designed to reach the larger Veteran population with messages promoting help seeking. However, what types of messages effectively change beliefs and behaviors for at-risk Veterans resistant to seek treatment is unclear. The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. This represents the first study to systematically develop public messaging strategies for populations at risk for suicide.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. A four-year mixed methods study that uses a sequential embedded design will be used to collect data from nationwide samples of Veterans at risk for suicide not in mental health treatment who separated from the DoD in the past year. Informed by the Theory of Planned Behavior, individual interviews will first be conducted to guide the design of effective public messages that will be subsequently tested in a two-arm RCT to determine exposure effects among targeted audience vs. control group. Messages will be disseminated to study participants during the trial by a smartphone app. Research staff will collect assessments by telephone at baseline, 1- and 3-months post-randomization. Potential participants (for all study aims) will be identified using data available from the VA/DOD Identity Repository (VADIR) and recruited by invitational mailing and follow-up telephone calls. If the intervention is found effective, the investigators will work with the VA operational partner to include messages in future outreach approaches to prevent Veteran suicide and use findings to improve current communication performance measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Canandaigua, New York, United States, 14424-1159
        • VA Finger Lakes Healthcare System, Canandaigua, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • U.S. Veteran that separated from military service in the past 12 months (any discharge type);
  • >18 years old;
  • experiencing suicidal ideation;
  • low intent to seek help;
  • capable of understanding the goals of the study;
  • willing and able to provide verbal consent; and 7) smartphone ownership and willing to download/use study mobile app

Exclusion Criteria:

  • currently (or in the past 12 months) in formal mental health treatment services;
  • deemed impaired during eligibility screening; and 3) currently institutionalized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Message Exposure
Participants exposed to 4 study videos over a one-month period and complete telephone-based assessments at baseline, 1- and 2-month follow up. Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.
Behavioral: Messaging
Four brief video messages, each approximately 1.5 minutes in length, focused on facilitating treatment seeking by addressing barriers and improving attitudes. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
Placebo Comparator: Wait List Control
While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study. Telephone-based assessments are completed at baseline, 1- and 2-month follow up. Push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.
Other: Wait list control
one push notification each week thanking individuals for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in treatment initiation from baseline to 1- and 2-month follow-up
Time Frame: baseline, 1-month and 2-month follow up
change in treatment initiation (yes/no)
baseline, 1-month and 2-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in beliefs about mental health and treatment seeking from baseline to 1- and 2-month follow-up
Time Frame: baseline, 1-month and 2-month follow up
Change in level of agreement with the following beliefs (a) attitudes toward treatment, (b) subjective norm, (c) perceived behavioral control over treatment is measured using a 7-point likert scale (7 indicating strong agreement)
baseline, 1-month and 2-month follow up
change in intentions to seek treatment from baseline to 1- and 2-month follow-up
Time Frame: baseline, 1-month and 2-month follow up
change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (7 indicating strong intent)
baseline, 1-month and 2-month follow up
change in perceived treatment barriers from baseline to 1- and 2-month follow-up
Time Frame: baseline, 1-month and 2-month follow up
change in level of agreement with barriers to mental health care that impede one's own behaviors measured using a response scale from 1 (strongly disagree) to 5 (strongly agree).
baseline, 1-month and 2-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Karras-Pilato, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDR 19-354
  • HX003130-01A2 (Other Grant/Funding Number: VA Health Services Research & Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only a Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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