Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans

February 6, 2023 updated by: Elizabeth Karras, Canandaigua VA Medical Center

Evaluation of the VA's Public Awareness Campaigns

This pilot study seeks to determine if exposure to the Make the Connection campaign messages developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in mental-health related outcomes, specifically: (1) psychosocial determinants that drive help seeking behaviors (knowledge, attitudes and intentions); and (2) perceived barriers to seeking care. Participants are randomly assigned to message exposure or control (no exposure) conditions. Data from this project will inform mental health education and outreach efforts targeted towards Veterans experiencing mental health concerns.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Veterans of all gender/sex, race/ethnicities that in the past 6 months:

  • utilized health services in the U.S. Department of Veterans Affairs (VA);
  • screened positive on the PHQ-2, AUDIT-C or PC-PTSD and/or received a mental health diagnosis as documented in VA medical record
  • Fluent in English language
  • Capable of understanding goals of study
  • Capable of providing verbal consent
  • Willing and able to download/use study Android mobile application for duration of study

Exclusion Criteria:

  • Not a U.S. Veteran who has utilized VA health care in the past 6 months
  • Did not screen positive and/or was not diagnosed with mental health disorder
  • Determined cognitively impaired and unable to provide verbal consent
  • Determined to be in high distress during recruitment screening
  • Currently institutionalized (i.e., hospitalized; incarcerated, etc.)
  • Unwilling and/or unable to download and use use the study app

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exposure to Make the Connection messages
Other: Exposure to Make the Connection messages
Participants are exposed to Make the Connection messages (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
ACTIVE_COMPARATOR: Active Control group
Other: Active Control Group
Participants are exposed to VA news clips/segments (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
NO_INTERVENTION: No exposure control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in help seeking behavior
Time Frame: change from baseline behavior at 16 weeks
self-report treatment engagement in VA or non-VA services
change from baseline behavior at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes towards help seeking
Time Frame: assessed up to 16 weeks
self-reported treatment beliefs and likelihood for help seeking
assessed up to 16 weeks
Barriers to care
Time Frame: assessed up to 16 weeks
The 6-item stigma Scale developed by Britt et al. (2000; 2008) to assess stigma of accessing treatment for psychological problems among military personnel is used w/a 5 point likert scale (1=strongly disagree to 5=strongly agree). Logistical barriers to care are also assessed using the 5-item Barriers to Care scale (Hoge et al. 2004) to assess barriers to accessing psychological treatment w/ a 5 point likert scale (1=strongly disagree; 5= strongly agree). Higher values represent a worse outcome (e.g., higher endorsement of stigma).
assessed up to 16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in social support
Time Frame: change from baseline behavior at 16 weeks
self-report survey using the multidimensional scale of perceived social support (Zimmet et al. 1990). This is a 12-item scale of perceived social support from family and friends. Each item is scored 1-7 on a likert scale (1=very strongly disagree; 7=very strongly agree) and summed with a possible range of 7 to 84. Higher scores indicate higher awareness/belief of social support.
change from baseline behavior at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canandaigua VA Medical Center

Investigators

  • Principal Investigator: Elizabeth Karras, PhD, Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

September 1, 2022

Study Completion (ACTUAL)

September 1, 2022

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB899190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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