Mental HealthNCT04784663

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

A study testing Messaging in people with Mental Health 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Mental Health, Suicide
What is being tested?: Messaging
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 355 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2022to 30 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

U.S. Veteran that separated from military service in the past 36 months or less (any discharge type);
>18 years old;
experiencing suicide risk;
low intent to seek help;
capable of understanding the goals of the study;
willing and able to provide verbal consent;
smartphone ownership and willing to download/use study mobile app

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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 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.

Conditions: Mental Health, Suicide
Being tested: Messaging, Wait list control
Keywords: communication, Veterans, public health, treatment engagement
Medical subject headings: Psychological Well-Being, Suicide, Communication

What participants receive

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

MessagingBehavioural
Four brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
Wait list controlOther
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.

Study groups in NCT04784663
Study group	Role	What they receive
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. Receives: Behavioral: Messaging
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. Receives: Behavioral: Messaging; Other: Wait list control
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. Receives: Other: Wait list control

What is being measured

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

Treatment Initiation
yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues.
Measured: baseline through 2-month follow-up

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline through 2-month follow up

Timeline

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

1 Dec 202230 Sep 2025

First posted5 Mar 2021
Study start1 Dec 2022
Primary completion30 Jun 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental HealthStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: None (open label)
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04784663
Sponsor's protocol ID: SDR 19-354
Other IDs: HX003130-01A2
Status last verified: Jun 2026
First submitted: 1 Mar 2021
Last updated: 9 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health

All Mental Health trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Public Messaging to Increase Treatment Seeking Among Veterans at Risk for Suicide During Transition From Military Service
ClinicalTrials.gov ID: NCT04784663
Acronym / sponsor ID: SDR 19-354
Conditions: Mental Health, Suicide
Keywords: communication, Veterans, public health, treatment engagement
Study type: Interventional
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Dec 2022 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 5 Mar 2021 (actual)
Results: Posted 9 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Immediate Message Exposure	Experimental	Behavioral: MessagingParticipants 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.
Wait List Control then message exposure at T2	Placebo comparator	Behavioral: Messaging, Other: Wait list controlParticipants 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.
Wait List Control then message exposure at T3	Placebo comparator	Other: Wait list controlParticipants 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.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

U.S. Veteran that separated from military service in the past 36 months or less (any discharge type);
>18 years old;
experiencing suicide risk;
low intent to seek help;
capable of understanding the goals of the study;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MessagingFour brief video messages focused on facilitating treatment seeking. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.	Behavioural	Immediate Message Exposure, Wait List Control then message exposure at T2
Wait list controlone 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.	Other	Wait List Control then message exposure at T2, Wait List Control then message exposure at T3

Primary outcome

Treatment Initiation
Time frame: baseline through 2-month follow-up
yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues.

4 secondary outcomes

Mean Change in Beliefs About Mental Health Treatment
Time frame: baseline through 2-month follow up
Mean Change in Intentions to Seek Treatment
Time frame: baseline through 2-month follow up
Mean Change in Perceived Treatment Barriers
Time frame: baseline through 2-month follow up
Mean Change in Normative Beliefs About Seeking Mental Health Care
Time frame: baseline through 2-month follow up

Results and safety

Results posted to the registry on 9 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Message Exposure	123	123
Wait List Control Then Message Exposure at T2	116	116
Wait List Control Then Exposure at T3	116	116

Primary outcome: Treatment Initiation

Time frame: baseline through 2-month follow-up. Count of participants. Unit: Participants

Measure	Message Exposure n = 229	Wait List Control n = 232
Value	34	19

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected over a 2-month study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Message Exposure	0 of 229 (0%)	0 of 229 (0%)	0 of 229
Wait List Control	0 of 232 (0%)	0 of 232 (0%)	0 of 232

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

Related trials for Mental Health

Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Karras, PhD principal investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Messaging in people with Mental Health 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 7 inclusion and 3 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 9 Jul 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment Initiation (time frame: baseline through 2-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784663.

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 9 Jul 2026.