- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04784663
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
355
Phase
- 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 Locations
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New York
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Canandaigua, New York, United States, 14424-1159
- VA Finger Lakes Healthcare System, Canandaigua, NY
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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)
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baseline, 1-month and 2-month follow up
|
Secondary Outcome Measures
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
|
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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
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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)
November 1, 2022
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 5, 2021
Study Record Updates
Last Update Posted (Estimated)
October 14, 2025
Last Update Submitted That Met QC Criteria
October 8, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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