NCT04784663

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

March 1, 2021

Results QC Date

May 15, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

communicationVeteranspublic healthtreatment engagement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Mean Change in Beliefs About Mental Health Treatment

    baseline through 2-month follow up

  • Mean Change in Intentions to Seek Treatment

    baseline through 2-month follow up

  • Mean Change in Perceived Treatment Barriers

    baseline through 2-month follow up

  • Mean Change in Normative Beliefs About Seeking Mental Health Care

    baseline through 2-month follow up

Study Arms (3)

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.

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.

Behavioral: MessagingOther: 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.

Other: Wait list control

Interventions

MessagingBEHAVIORAL

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

Immediate Message ExposureWait List Control then message exposure at T2

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.

Wait List Control then message exposure at T2Wait List Control then message exposure at T3

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

MeSH Terms

Conditions

Psychological Well-BeingSuicideCommunication

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSelf-Injurious BehaviorBehavioral Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Elizabeth Karras
Organization
Department of Veterans Affairs

Study Officials

  • Elizabeth Karras, PhD

    VA Finger Lakes Healthcare System, Canandaigua, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

December 1, 2022

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

July 9, 2026

Results First Posted

July 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations