- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04784663
Public Messaging to Increase Treatment Seeking for Veterans at Risk for Suicide
Public Messaging to Increase Treatment Seeking Among Veterans at Risk for Suicide During Transition From Military Service
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Canandaigua, New York, United States, 14424-1159
- VA Finger Lakes Healthcare System, Canandaigua, NY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- U.S. Veteran that separated from military service in the past 36 months or less (any discharge type);
- >18 years old;
- experiencing suicide risk;
- low intent to seek help;
- capable of understanding the goals of the study;
- willing and able to provide verbal consent;
- smartphone ownership and willing to download/use study mobile app
Exclusion Criteria:
- currently (or in the past 12 months) in formal mental health treatment services;
- deemed impaired during eligibility screening;
- currently institutionalized
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Message Exposure
Participants complete baseline (T1) and are randomly assigned to immediately receive 4 study videos over the first month.
The exposure period ends and participants complete telephone-based assessments at 1- and 2-month follow up (T2 and T3 respectively).
Study videos are delivered by study's mobile app downloaded to participants' own Smartphone.
|
Four brief video messages focused on facilitating treatment seeking.
Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
|
|
Placebo Comparator: Wait List Control then message exposure at T2
Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study. Following the 1-month follow up (T2), they receive videos over a one month period. The exposure period ends and participants complete the 2-month follow up (T3) assessment by telephone. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
one push notification each week thanking individuals for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.
Four brief video messages focused on facilitating treatment seeking.
Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
|
|
Placebo Comparator: Wait List Control then message exposure at T3
Participants complete baseline and are randomly assigned to the waitlist control. While wait-listed, participants will receive one push notification each week thanking them for participation, informing them that they will receive messages in the near future or reminding them of the length of the study. Following completion of the 2 month follow-up (T3), participants receive videos over a one month period. They are not assessed post-exposure. Videos and push notifications are delivered by study's mobile app downloaded to participants' own Smartphone. |
one push notification each week thanking individuals for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Initiation
Time Frame: baseline through 2-month follow-up
|
yes to initiating psychological treatment and/or medication/pharmacological treatment in the past month to treat mental health issues.
|
baseline through 2-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Beliefs About Mental Health Treatment
Time Frame: baseline through 2-month follow up
|
Beliefs about mental health treatment was assessed using the "Perceptions about Services Scale" with individuals endorsing items on a scale from 1 (lowest agreement) to 7 (higher agreement).
A mean is calculated across items to create a composite score (higher score = greater positive beliefs about mental health treatment); lowest score = 1; highest score = 7.
|
baseline through 2-month follow up
|
|
Mean Change in Intentions to Seek Treatment
Time Frame: baseline through 2-month follow up
|
change in intent to seek mental health treatment in the next month measured using a 7-point likert scale (1 indicating low intent and 7 indicating strong intent) from items in the "Perceptions about Services Scale."
A mean is calculated (higher score representing higher intentions) to create a composite score on the scale.
lowest score = 1; highest score = 7.
|
baseline through 2-month follow up
|
|
Mean Change in Perceived Treatment Barriers
Time Frame: baseline through 2-month follow up
|
Used the "Perceived Stigma and Barriers to Care scale" to assess change in agreement with barriers to mental health care that impede one's own behaviors measured using a response scale from 1 (strongly disagree) to 5 (strongly agree).
A mean is calculated across items to create a cumulative score (higher score = more experience with barriers to care).lowest
score = 1; highest score = 5.
|
baseline through 2-month follow up
|
|
Mean Change in Normative Beliefs About Seeking Mental Health Care
Time Frame: baseline through 2-month follow up
|
Items assessing subjective norms on seeking mental health care were used from "Perceptions about Services Scale" with scores ranging from 1 (low agreement) to 7 (high agreement).
A mean was calculated to create a cumulative score (higher score = greater positive perceptions about seeking mental health care); 1 = lowest score; 7 = highest score.
|
baseline through 2-month follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth Karras, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR 19-354
- HX003130-01A2 (Other Grant/Funding Number: VA Health Services Research & Development)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Suicide
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
-
Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityActive, not recruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Mental Health Services in the Capital Region, DenmarkCompletedSuicide Prevention | Suicidal Thoughts | Suicide AttemptsDenmark
Clinical Trials on Wait list control
-
New York State Psychiatric InstituteCompletedCognitive Deterioration | Disorder of AgingUnited States
-
University of OsloNorwegian Institute of Public Health; Norwegian Council for Mental Health; The...CompletedQuality of Life | Wellbeing | Health AttitudeNorway
-
New York State Psychiatric InstituteFeinstein Institute for Medical ResearchCompleted
-
University of Alabama at BirminghamNational Cancer Institute (NCI)Completed
-
Kaohsiung Medical University Chung-Ho Memorial...Kaohsiung Medical UniversityUnknownHead and Neck CancerTaiwan
-
Macmillan Research Group UKNMP Medical Research Institute; Warwick Research ServicesUnknownRheumatic ArthritisIndia
-
Washington University School of MedicineRecruitingCardiovascular Diseases | ObesityUnited States
-
Seattle Children's HospitalCompleted
-
Memorial Sloan Kettering Cancer CenterCompletedBreast Cancer | Gynecologic Cancer | Peripheral NeuropathyUnited States
-
University Health Network, TorontoUniversity of British Columbia; University of Toronto; Dalhousie University; Canadian... and other collaboratorsCompleted