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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04784663
• Other study ID #: SDR 19-354
• Secondary ID: HX003130-01A2
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Elizabeth Karras-Pilato, PhD
• Phone: (585) 393-7285
• Email: Elizabeth.Karras-Pilato[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Suicide

Intervention

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.

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.

Locations

Country	Name	City	State
United States	VA Finger Lakes Healthcare System, Canandaigua, NY	Canandaigua	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in treatment initiation from baseline to 1- and 2-month follow-up	change in treatment initiation (yes/no)	baseline, 1-month and 2-month follow up
Secondary	change in beliefs about mental health and treatment seeking from baseline to 1- 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
Secondary	change in intentions to seek treatment from baseline to 1- 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
Secondary	change in perceived treatment barriers from baseline to 1- 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