CClinicalTrials.gg
WithdrawnNCT03407443Updated Feb 8, 2023

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

An interventional study of Exposure to Make the Connection messages and Active Control Group in Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Help-Seeking Behavior, sponsored by Canandaigua VA Medical Center. Withdrawn. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Canandaigua VA Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • mental health promotion campaign
  • veterans
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Exposure to Make the Connection messages

    Other: Exposure to Make the Connection messages

  • Active comparator
    Active Control group

    Other: Active Control Group

  • No intervention
    No exposure control group

Interventions

  • OtherExposure 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.

  • OtherActive 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.

05

What researchers measure

Primary outcomes

  1. change in help seeking behavior

    self-report treatment engagement in VA or non-VA services

    Time frame: change from baseline behavior at 16 weeks

Secondary outcomes

  1. Attitudes towards help seeking

    self-reported treatment beliefs and likelihood for help seeking

    Time frame: assessed up to 16 weeks

  2. 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).

    Time frame: assessed up to 16 weeks

Other outcomes

  1. change in social support

    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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03407443
Lead sponsor
Canandaigua VA Medical Center
Responsible party
Elizabeth Karras (Health Science Specialist, Canandaigua VA Medical Center) — Principal investigator
First posted
Jan 23, 2018
Start date
Jul 2016
Primary completion
Sep 2022
Completion
Sep 2022
Last update
Feb 8, 2023

Study contacts

Elizabeth Karras, PhD
principal investigator · Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion