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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03407443
Other study ID # IRB899190
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date September 2022

Study information

Verified date February 2023
Source Canandaigua VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Canandaigua VA Medical Center

Outcome

Type Measure Description Time frame Safety issue
Other 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. change from baseline behavior at 16 weeks
Primary change in help seeking behavior self-report treatment engagement in VA or non-VA services change from baseline behavior at 16 weeks
Secondary Attitudes towards help seeking self-reported treatment beliefs and likelihood for help seeking assessed up to 16 weeks
Secondary 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). assessed up to 16 weeks
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