NCT03407443

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6.2 years

First QC Date

January 9, 2018

Last Update Submit

February 6, 2023

Conditions

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

Keywords

mental health promotion campaignveterans

Outcome Measures

Primary Outcomes (1)

  • change in help seeking behavior

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

    change from baseline behavior at 16 weeks

Secondary Outcomes (2)

  • Attitudes towards help seeking

    assessed up to 16 weeks

  • Barriers to care

    assessed up to 16 weeks

Other Outcomes (1)

  • change in social support

    change from baseline behavior at 16 weeks

Study Arms (3)

Exposure to Make the Connection messages

EXPERIMENTAL
Other: Exposure to Make the Connection messages

Active Control group

ACTIVE COMPARATOR
Other: Active Control Group

No exposure control group

NO INTERVENTION

Interventions

Exposure to Make the Connection messagesOTHER

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.

Exposure to Make the Connection messages
Active Control GroupOTHER

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.

Active Control group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionPsychotic DisordersPersonality DisordersSubstance-Related DisordersHelp-Seeking Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced DisordersSocial Behavior

Study Officials

  • Elizabeth Karras, PhD

    Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Science Specialist

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 23, 2018

Study Start

July 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02