Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)NCT03407443
Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans
A study testing Exposure to Make the Connection messages in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Help-Seeking Behavior, run by Canandaigua VA Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Help-Seeking Behavior
- What is being tested?
- Exposure to Make the Connection messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Help-Seeking Behavior
- Being tested
- Exposure to Make the Connection messages, Active Control Group
- Keywords
- mental health promotion campaign, veterans
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure to Make the Connection messages | Experimental | Not described Receives: Other: Exposure to Make the Connection messages |
| Active Control group | Active comparator | Not described Receives: Other: Active Control Group |
| No exposure control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in help seeking behavior
self-report treatment engagement in VA or non-VA services
Measured: change from baseline behavior at 16 weeks
Secondary outcomes (2)
Attitudes towards help seeking
self-reported treatment beliefs and likelihood for help seeking
Measured: assessed up to 16 weeks
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).
Measured: assessed up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startJul 2016
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Elizabeth Karras, Canandaigua VA Medical Center
- Investigators
- Elizabeth Karras, PhD, Principal investigator, Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407443
- Sponsor's protocol ID
- IRB899190
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the VA's Public Awareness Campaigns
- ClinicalTrials.gov ID
- NCT03407443
- Acronym / sponsor ID
- IRB899190
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Help-Seeking Behavior
- Keywords
- mental health promotion campaign, veterans
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to Make the Connection messagesParticipants 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. | Other | Exposure to Make the Connection messages |
| Active Control GroupParticipants 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. | Other | Active Control group |
Primary outcome
change in help seeking behavior
Time frame: change from baseline behavior at 16 weeks
self-report treatment engagement in VA or non-VA services
2 secondary outcomes
Attitudes towards help seeking
Time frame: assessed up to 16 weeks
Barriers to care
Time frame: assessed up to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Karras, PhD principal investigator
Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to Make the Connection messages in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Help-Seeking Behavior, run by Canandaigua VA Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in help seeking behavior (time frame: change from baseline behavior at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.