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

Primary Purpose

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Help-Seeking Behavior

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exposure to Make the Connection messages
Active Control Group
Sponsored by
Canandaigua VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) focused on measuring mental health promotion campaign, veterans

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Exposure to Make the Connection messages

    Active Control group

    No exposure control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    change in help seeking behavior
    self-report treatment engagement in VA or non-VA services

    Secondary Outcome Measures

    Attitudes towards help seeking
    self-reported treatment beliefs and likelihood for help seeking
    Barriers to care
    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).

    Full Information

    First Posted
    January 9, 2018
    Last Updated
    February 6, 2023
    Sponsor
    Canandaigua VA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03407443
    Brief Title
    Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans
    Official Title
    Evaluation of the VA's Public Awareness Campaigns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    September 2022 (Actual)
    Study Completion Date
    September 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Canandaigua VA Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Help-Seeking Behavior
    Keywords
    mental health promotion campaign, veterans

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exposure to Make the Connection messages
    Arm Type
    Experimental
    Arm Title
    Active Control group
    Arm Type
    Active Comparator
    Arm Title
    No exposure control group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Exposure to Make the Connection messages
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Active Control Group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    change in help seeking behavior
    Description
    self-report treatment engagement in VA or non-VA services
    Time Frame
    change from baseline behavior at 16 weeks
    Secondary Outcome Measure Information:
    Title
    Attitudes towards help seeking
    Description
    self-reported treatment beliefs and likelihood for help seeking
    Time Frame
    assessed up to 16 weeks
    Title
    Barriers to care
    Description
    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).
    Time Frame
    assessed up to 16 weeks
    Other Pre-specified Outcome Measures:
    Title
    change in social support
    Description
    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.
    Time Frame
    change from baseline behavior at 16 weeks

    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Karras, PhD
    Organizational Affiliation
    Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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