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Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training

Primary Purpose

Suicide Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PsychArmor S.A.V.E.
sham intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide Prevention focused on measuring suicide, suicide prevention, mental health, veterans

Eligibility Criteria

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

Inclusion Criteria:

  • A veteran who has served on active duty in the U.S. Armed Forces within the prior 12 months, OR a person who feels "close to" a veteran; AND
  • Social contact with a veteran at least weekly

Exclusion Criteria:

  • Lack a U.S. phone number, email, or computer access; OR
  • Not fluent in English; OR
  • Have previously taken or intend to take PsychArmor S.A.V.E. training; OR
  • Duplicate study entry or misrepresentation of veteran status.

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

treatment arm

sham arm

Arm Description

Participants in this arm will receive the intervention, PsychArmor S.A.V.E.

Participants in this arm will receive a "sham" training, not the intervention, consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.

Outcomes

Primary Outcome Measures

recruitment
number enrolled; proportion of eligible who enroll
survey completion rates change
survey completion at each survey timepoint

Secondary Outcome Measures

training completion
proportion of training completed
satisfaction
an 8-item satisfaction questionnaire, adapted from the CSQ-8, where higher scores indicate greater satisfaction

Full Information

First Posted
September 21, 2020
Last Updated
July 13, 2022
Sponsor
VA Office of Research and Development
Collaborators
Canandaigua VA Medical Center, PsychArmor Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04565951
Brief Title
Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training
Official Title
Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training: A Pilot Study of PsychArmor S.A.V.E.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2021 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Canandaigua VA Medical Center, PsychArmor Institute

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
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the feasibility and acceptability of a gatekeeper training called PsychArmor S.A.V.E. which was developed through a partnership between the VA and the PsychArmor Training Institute. Gatekeeper training teaches "gatekeepers" skills in how to identify a person with suicide risk, inquire about suicidal thoughts, and help make a connection to professional treatment. PsychArmor S.A.V.E. is a brief, novel online gatekeeper training that was created and designed specifically for Veterans and their family and friends. In this study, the investigators will recruit Veterans who have recently transitioned out of the military, as well as their family and friends. Participants in the study will be asked to complete a survey, watch the PsychArmor S.A.V.E. training, and complete several follow-up surveys over six months. A small subset of participants will also be invited to participate in an interview.
Detailed Description
Background: Suicide is an urgent public health crisis, and transitioning Veterans (those who have recently separated from the military) are a high-risk group for suicide. A key component to advancing suicide prevention efforts among at-risk Veterans is to address low levels of help-seeking and engagement in treatment, including Veterans Health Administration (VHA) care. Veterans are most likely to disclose suicidal thoughts to their close supports-family members, friends, and their peers. However, Veterans and their close supports rarely receive training in how to help a peer at risk of suicide, despite strong interest in such training. Gatekeeper training is a key strategy with potential to help address these challenges. Gatekeeper training teaches "gatekeepers" skills in how to identify a Veteran with suicide risk, inquire about suicidal thoughts, and help make a connection to professional treatment; it may benefit the trainee's own mental health too. PsychArmor S.A.V.E., developed through a partnership between the VA and the PsychArmor Training Institute, is a brief, novel online gatekeeper training designed for Veterans and their close supports. Significance/Impact: This project focuses on VA's topic clinical priority, suicide prevention. The 2019 VA and Department of Defense Clinical Practice Guidelines also identified gatekeeper training as an important research gap and priority for future research. This research design addresses three separate goals and objectives contained in VA's National Strategy for Preventing Veteran Suicide, including involvement of Veterans' close supports. Innovation: This proposal employs the novel approach of recruiting Veterans and their close supports through online social media advertisements, allowing for broad outreach, suicide prevention targeting Veterans outside the VA network, and the potential to test the effectiveness of gatekeeper training on a large scale. Online gatekeeper trainings are highly scalable public health strategies with the potential to diffuse through online social networks. Specific Aims: The primary objective is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility and acceptability of the online gatekeeper training PsychArmor S.A.V.E. To reach this objective the investigators will achieve these aims: 1) Determine the feasibility of recruiting participants via social media, engaging them to participate in an online gatekeeper training program, and retaining them in an online intervention study; and 2) Determine the acceptability of PsychArmor S.A.V.E. in a pilot RCT, and evaluate measures for use in a future larger-scale RCT. Methodology: This is a two-arm pilot randomized clinical trial involving 200 participants. Participants will be recruited through social media advertisements targeting transitioning Veterans and their close supports (family and friends). Participants will be randomized to take the PsychArmor S.A.V.E. gatekeeper training or a "sham" control training and followed for 6 months. Mixed quantitative and qualitative methods will be used to assess outcomes on feasibility and acceptability. Additional data collection and analysis of measures related to suicide prevention, such as gatekeeper behaviors, knowledge, stigma, self-efficacy, and social norms measures will help prepare for a larger-scale RCT. Implementation/Next Steps: By using an extremely scalable intervention and building off existing VA practices and partnerships, this project will be very well-positioned for further evaluation and implementation into VA practice if found to be effective. It is freely available online, making it highly amenable to being rapidly taken to scale. Results of this project will inform future efforts to disseminate and/or revise PsychArmor S.A.V.E.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention
Keywords
suicide, suicide prevention, mental health, veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to either the intervention or the control group. Block-randomization schemes using random block sizes to assign the two study arms will be created in R using the blockrand package before study start and pre-loaded into survey software. The intervention, called PsychArmor S.A.V.E., is an online, video-based training tailored to veterans and their close supports. The control group will consist of a "sham" training - a different online, video-based training course developed by the PsychArmor Institute for military service members, veterans, and their loved ones. Topics in this "sham" training may include information relevant to transitioning veterans and their loved ones, such as preparing finances, networking, searching for a job, and using educational benefits. The length of the training will be matched to the intervention (24 minutes) and the "sham" training will also contains other design features similar to the intervention (e.g., motion graphics).
Masking
ParticipantInvestigator
Masking Description
Participants will be blinded by limiting details about the study hypotheses and differences between the study arms. Blinding will also be achieved because no study personnel are involved in intervention delivery. The biostatistician will be blinded for analyses involving study group comparisons.
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
Participants in this arm will receive the intervention, PsychArmor S.A.V.E.
Arm Title
sham arm
Arm Type
Sham Comparator
Arm Description
Participants in this arm will receive a "sham" training, not the intervention, consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.
Intervention Type
Behavioral
Intervention Name(s)
PsychArmor S.A.V.E.
Intervention Description
The intervention is called PsychArmor S.A.V.E. It is an online video-based training tailored to veterans and their close supports. It is free, brief (24 minutes), and includes three scripted role plays.
Intervention Type
Behavioral
Intervention Name(s)
sham intervention
Intervention Description
A "sham" training consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.
Primary Outcome Measure Information:
Title
recruitment
Description
number enrolled; proportion of eligible who enroll
Time Frame
baseline (T=0)
Title
survey completion rates change
Description
survey completion at each survey timepoint
Time Frame
1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-up
Secondary Outcome Measure Information:
Title
training completion
Description
proportion of training completed
Time Frame
baseline (T=0)
Title
satisfaction
Description
an 8-item satisfaction questionnaire, adapted from the CSQ-8, where higher scores indicate greater satisfaction
Time Frame
baseline (T=0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A veteran who has served on active duty in the U.S. Armed Forces within the prior 12 months, OR a person who feels "close to" a veteran; AND Social contact with a veteran at least weekly Exclusion Criteria: Lack a U.S. phone number, email, or computer access; OR Not fluent in English; OR Have previously taken or intend to take PsychArmor S.A.V.E. training; OR Duplicate study entry or misrepresentation of veteran status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan R. Teo, MD MS
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training

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