Clinical trial NCT04784663: Public Messaging to Increase Treatment Seeking for Veterans at Risk for Suicide
Official title: Public Messaging to Increase Treatment Seeking Among Veterans at Risk for Suicide During Transition From Military Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Suicide
Keywords: communication
Veterans
public health
treatment engagement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-03-05
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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 baseline (T1), 1-month (T2) or 2-month follow up (T3). Exposure to intervention occurs over a 1-month period.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in treatment initiation from baseline to 1- and 2-month follow-up
timeFrame: baseline, 1-month and 2-month follow up
Secondary outcomes:
measure: change in beliefs about mental health and treatment seeking from baseline to 1- and 2-month follow-up
timeFrame: baseline, 1-month and 2-month follow up
measure: change in intentions to seek treatment from baseline to 1- and 2-month follow-up
timeFrame: baseline, 1-month and 2-month follow up
measure: change in perceived treatment barriers from baseline to 1- and 2-month follow-up
timeFrame: baseline, 1-month and 2-month follow up
Other outcomes:
Locations:
city: Canandaigua
country: United States
facility: VA Finger Lakes Healthcare System, Canandaigua, NY
state: New York
Study officials:
affiliation: VA Finger Lakes Healthcare System, Canandaigua, NY
name: Elizabeth Karras-Pilato, PhD
role: PRINCIPAL_INVESTIGATOR
References: