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

Primary Purpose

Mental Health, Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Messaging
Wait list control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health focused on measuring communication, Veterans, public health, treatment engagement

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Canandaigua VA Medical Center, Canandaigua, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Message Exposure

Wait List Control

Arm Description

Participants exposed to 4 study videos over a one-month period and complete telephone-based assessments at baseline, 1- and 2-month follow up. Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.

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. Telephone-based assessments are completed at baseline, 1- and 2-month follow up. Push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.

Outcomes

Primary Outcome Measures

change in treatment initiation from baseline to 1- and 2-month follow-up
change in treatment initiation (yes/no)

Secondary Outcome Measures

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)
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)
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).

Full Information

First Posted
March 1, 2021
Last Updated
November 28, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04784663
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, Suicide
Keywords
communication, Veterans, public health, treatment engagement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Message Exposure
Arm Type
Experimental
Arm Description
Participants exposed to 4 study videos over a one-month period and complete telephone-based assessments at baseline, 1- and 2-month follow up. Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.
Arm Title
Wait List Control
Arm Type
Placebo Comparator
Arm Description
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. Telephone-based assessments are completed at baseline, 1- and 2-month follow up. Push notifications are delivered by study's mobile app downloaded to participants' own Smartphone.
Intervention Type
Behavioral
Intervention Name(s)
Messaging
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait list control
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in treatment initiation from baseline to 1- and 2-month follow-up
Description
change in treatment initiation (yes/no)
Time Frame
baseline, 1-month and 2-month follow up
Secondary Outcome Measure Information:
Title
change in beliefs about mental health and treatment seeking from baseline to 1- and 2-month follow-up
Description
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)
Time Frame
baseline, 1-month and 2-month follow up
Title
change in intentions to seek treatment from baseline to 1- and 2-month follow-up
Description
change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (7 indicating strong intent)
Time Frame
baseline, 1-month and 2-month follow up
Title
change in perceived treatment barriers from baseline to 1- and 2-month follow-up
Description
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).
Time Frame
baseline, 1-month and 2-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Karras-Pilato, PhD
Phone
(585) 393-7285
Email
Elizabeth.Karras-Pilato@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa B Lochner
Phone
(585) 393-7663
Email
lisa.lochner@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Karras-Pilato, PhD
Organizational Affiliation
Canandaigua VA Medical Center, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canandaigua VA Medical Center, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Gillespie, MD BS
Phone
585-393-7763
Email
Suzanne.Gillespie@va.gov
First Name & Middle Initial & Last Name & Degree
Dorian L Savino, MPA
Phone
(585) 463-2673
Email
dorian.savino@va.gov
First Name & Middle Initial & Last Name & Degree
Elizabeth Karras-Pilato, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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