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| ID | Type | Description | Link |
|---|---|---|---|
| HX003130-01A2 | Other Grant/Funding Number | VA Health Services Research & Development |
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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.
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 an RCT to determine exposure effects among targeted audience vs. waitlist control. 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 2-months post-randomization. Potential participants will primarily 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Message Exposure | Experimental | Participants complete baseline (T1) and are randomly assigned to immediately receive 4 study videos over the first month. The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3 respectively). Study videos are delivered by study's mobile app downloaded to participants' own Smartphone. |
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| Wait List Control then message exposure at T2 | Placebo Comparator | Participants complete baseline and are randomly assigned to the waitlist 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. Following the 1-month follow up (T2), they receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
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| Wait List Control then message exposure at T3 | Placebo Comparator | Participants complete baseline and are randomly assigned to the waitlist 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. Following completion of the 2 month follow-up (T3), participants receive videos over a one month period. They are not assessed post-exposure. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Messaging | Behavioral | Four brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Initiation | yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues. | baseline through 2-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Beliefs About Mental Health Treatment | Beliefs about mental health treatment was assessed using the "Perceptions about Services Scale" with individuals endorsing items on a scale from 1 (lowest agreement) to 7 (higher agreement). A mean is calculated across items to create a composite score (higher score = greater positive beliefs about mental health treatment); lowest score = 1; highest score = 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Karras, PhD | VA Finger Lakes Healthcare System, Canandaigua, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Finger Lakes Healthcare System, Canandaigua, NY | Canandaigua | New York | 14424-1159 | United States |
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.
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A national random sample was recruited for the trial from December 2022 through April 2025 using the VA and DoD administrative records of those who recently separated from active components of service branches plus activated National Guard/Reservists. These records were queried monthly to randomly select individuals for recruitment, which involved emailing a flyer with a link to a Qualtrics study screener. Follow-up telephone calls were made to enroll those interested and eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Message Exposure | Participants complete baseline (T1), are randomized, and immediately receive 4 study videos over the first month. The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3, respectively). Study videos are delivered by the study's mobile app downloaded to the participants' own SmartPhone. Messaging: Four brief video messages that feature stories focused on the decision to seek mental health treatment. |
| FG001 | Wait List Control Then Message Exposure at T2 | Participants complete baseline and are randomized to the arm, "wait list control then message exposure at T2." 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. Following completion of the 1-month assessment (T2), participants receive videos over 1 month period. The exposure period ends and participants complete the 2-month follow up (T3) by telephone. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
| FG002 | Wait List Control Then Exposure at T3 | Participants complete baseline and are randomized to the arm, "wait list control then message exposure at T3." 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. Following completion of the 2-month assessment (T3), participants receive videos over 1 month period. The exposure period ends. There is no subsequent assessment following exposure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (T1) |
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| 1-month Follow-up (T2) |
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| 2 Month Follow-up (T3) |
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| Analysis |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Message Exposure | Participants complete baseline (T1) and are randomly assigned to immediately receive 4 study videos over the first month. The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3 respectively). Study videos are delivered by study's mobile app downloaded to participants' own Smartphone. Messaging: Four brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Initiation | yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues. | The Ns are distinct; Participants exposed at T2 contribute data as control and intervention depending on timing and outcome status (exposure is time-varying for this arm). Participants in this arm contributed data as controls (unexposed) for T1 and T2 until they received the intervention. Participants that had already experienced the outcome prior to crossover continued to contribute data as controls, whereas those who had not yet experienced the outcome were intervention observations for T3. | Posted | Count of Participants | Participants | baseline through 2-month follow-up |
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Data were collected over a 2-month study period.
AE and SAEs were defined as per clinicaltrials.gov protocols.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Message Exposure | all participants in the "immediate exposure arm" + all participants in the "waitlist then exposure at T2" arm who had not yet initiated treatment prior to crossover Messaging: Four brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone. |
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This study represents initial steps to understand how public messages can be used to promote treatment initiation in at-risk populations. Findings may not be generalizable to real world campaign practice. Continued research is needed to assess exposure effects at the population-level, within other contexts and among other at-risk populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Karras | Department of Veterans Affairs | 585-393-9350 | elizabeth.karras-pilato@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2026 | Feb 17, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 17, 2026 | Jun 11, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D013405 | Suicide |
| D003142 | Communication |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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All participants will complete the consent process and baseline assessment by telephone with an RA and are randomized to receive the intervention at either immediately following baseline (T1), at 1-month (T2) or 2-month follow up (T3). Exposure to intervention occurs over a 1-month period.
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| Wait list control | Other | 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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| baseline through 2-month follow up |
| Mean Change in Intentions to Seek Treatment | change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (1 indicating low intent and 7 indicating strong intent) from items in the "Perceptions about Services Scale." A mean is calculated (higher score representing higher intentions) to create a composite score on the scale. lowest score = 1; highest score = 7. | baseline through 2-month follow up |
| Mean Change in Perceived Treatment Barriers | Used the "Perceived Stigma and Barriers to Care scale" to assess change in 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). A mean is calculated across items to create a cumulative score (higher score = more experience with barriers to care).lowest score = 1; highest score = 5. | baseline through 2-month follow up |
| Mean Change in Normative Beliefs About Seeking Mental Health Care | Items assessing subjective norms on seeking mental health care were used from "Perceptions about Services Scale" with scores ranging from 1 (low agreement) to 7 (high agreement). A mean was calculated to create a cumulative score (higher score = greater positive perceptions about seeking mental health care); 1 = lowest score; 7 = highest score. | baseline through 2-month follow up |
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| BG001 | Wait List Control Then Message Exposure at T2 | Participants complete baseline and are randomly assigned to the waitlist control until receive videos at T2 (following 1-month follow up assessment). Participants receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone. 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. Push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. Messaging: Four brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone. 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. |
| BG002 | Wait List Control Then Message Exposure at T3 | Participants complete baseline and are randomly assigned to receive videos following their 2-month assessment at T3. Participants receive videos over a one month period. They are not assessed post-exposure. 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. Push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Time since military separation | Count of Participants | Participants |
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| Rank at Separation | Count of Participants | Participants |
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| Health Insurance | Count of Participants | Participants |
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| OG001 | Wait List Control | the waitlist control group = all timepoints/participants in the "waitlist then exposure at T3 arm" (received intervention at end-of-trial) + T3 data for participants in the "waitlist then exposure at T2 arm" who initiated treatment prior to crossover. |
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| Secondary | Mean Change in Beliefs About Mental Health Treatment | Beliefs about mental health treatment was assessed using the "Perceptions about Services Scale" with individuals endorsing items on a scale from 1 (lowest agreement) to 7 (higher agreement). A mean is calculated across items to create a composite score (higher score = greater positive beliefs about mental health treatment); lowest score = 1; highest score = 7. | Number analyzed = the overall/final N in each condition. Given the cross-over design, participants in group 2 contribute observations to both conditions depending on timing and outcome status (exposure is time-varying for this arm). | Posted | Mean | Standard Deviation | score on scale | baseline through 2-month follow up |
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| Secondary | Mean Change in Intentions to Seek Treatment | change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (1 indicating low intent and 7 indicating strong intent) from items in the "Perceptions about Services Scale." A mean is calculated (higher score representing higher intentions) to create a composite score on the scale. lowest score = 1; highest score = 7. | Number analyzed = the overall/final N in each condition. Given the cross-over design, participants in group 2 contribute observations to both conditions depending on timing and outcome status (exposure is time-varying for this arm). | Posted | Mean | Standard Deviation | score on scale | baseline through 2-month follow up |
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| Secondary | Mean Change in Perceived Treatment Barriers | Used the "Perceived Stigma and Barriers to Care scale" to assess change in 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). A mean is calculated across items to create a cumulative score (higher score = more experience with barriers to care).lowest score = 1; highest score = 5. | Number analyzed = the overall/final N in each condition. Given the cross-over design, participants in group 2 contribute observations to both conditions depending on timing and outcome status (exposure is time-varying for this arm). | Posted | Mean | Standard Deviation | score on scale | baseline through 2-month follow up |
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| Secondary | Mean Change in Normative Beliefs About Seeking Mental Health Care | Items assessing subjective norms on seeking mental health care were used from "Perceptions about Services Scale" with scores ranging from 1 (low agreement) to 7 (high agreement). A mean was calculated to create a cumulative score (higher score = greater positive perceptions about seeking mental health care); 1 = lowest score; 7 = highest score. | Number analyzed = the overall/final N in each condition. Given the cross-over design, participants in group 2 contribute observations to both conditions depending on timing and outcome status (exposure is time-varying for this arm). | Posted | Mean | Standard Deviation | score on scale | baseline through 2-month follow up |
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| 0 |
| 229 |
| 0 |
| 229 |
| 0 |
| 229 |
| EG001 | Wait List Control | All participants in the "waitlist then exposure at T3 arm" + all participants in the "waitlist then exposure at T2" arm who had already experienced the outcome prior to crossover 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. | 0 | 232 | 0 | 232 | 0 | 232 |
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