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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canandaigua VA Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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