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Behavioral health problems among Veterans have raised awareness of the critical need for more reliable, effective, and accessible ways to recognize those in need, direct them to help, and ensure that they receive the best evidence-based care available. AboutFace is a novel peer education program that features the personal stories of Veterans and is designed to improve Veterans' likelihood of engaging in Post Traumatic Stress Disorder (PTSD) specialty care. Using a randomized controlled study design the investigators propose to compare the efficacy of AboutFace relative to standard care for improving treatment engagement and outcomes. Additional data from VA providers will provide valuable information on wide scale implementation and dissemination of AboutFace. If AboutFace increases access of services, data will have broad implications for overcoming barriers to care for Veterans with PTSD and other stigmatized conditions.
Anticipated Impacts on Veterans Health Care: Behavioral health problems among Veterans have raised awareness of the critical need for more reliable, effective, and accessible means to recognize those in need, direct them to help, and ensure that they receive the best treatment available. Research has suggested that people are most responsive to advice and education when it comes from someone to whom they can relate. AboutFace is a peer education resource for Veterans that was developed, launched, and recently updated by the National Center for PTSD (NCPTSD) based on Health Services Research &Development (HSR&D) funded pilot data. AboutFace features personal stories of Veterans and is designed to improve mental health treatment engagement among Veterans with PTSD and related comorbidities. The study team, which includes the NCPTSD, recently completed a usability assessment and pilot feasibility trial of AboutFace under HSR&D grant #14-360-1. Data from this study (1) guided improvements to AboutFace for increasing PTSD treatment initiation and engagement; and (2) demonstrated the feasibility of the methodology for the proposed study. If AboutFace is found to increase Veterans' initiation and engagement in PTSD treatment, study data will have broad implications for overcoming barriers to care for Veterans with PTSD and other stigmatized conditions.
Background: At least 1 in 10 Veterans meet criteria for PTSD related to their military experience. Treatment for PTSD is widely available, and national dissemination initiatives have increased Veterans' access to best-practice interventions. However, treatment-seeking remains strikingly low; most Veterans with PTSD do not seek mental health services due to perceived stigma and other barriers. NCPTSD developed and launched AboutFace, a public awareness campaign to help Veterans recognize PTSD and motivate them to seek evidence-based care. Since its development, AboutFace has earned three major awards and has had tens of thousands of visits. Despite the tremendous potential for AboutFace to reduce stigma, improve attitudes toward mental health treatment seeking, and to increase PTSD treatment initiation and engagement, it has yet to be formally evaluated or effectively implemented within Veterans Health Administration (VHA) practice settings. In addition to providing needed data on the efficacy of AboutFace and identifying strategies for effective implementation within VHA, this study will provide a greater understanding of the role and value of digital storytelling interventions to improve access to care for a wide range of stigmatized conditions.
Objectives: The primary objectives of the study are to examine the impact of AboutFace on a) increasing PTSD treatment initiation and engagement; and b) decreasing stigma and negative attitudes toward mental health services. It is anticipated that Veterans in the AboutFace condition will be more likely to access and complete treatment than those receiving enhanced Usual Care (eUC) for PTSD. Finally, qualitative interviews with key stakeholders across the nation will be conducted to inform best practices for future implementation of AboutFace.
Methods: A total of 376 Veterans referred for a PTSD assessment and recommended for treatment in the Charleston PTSD clinic will be enrolled in the study. Veterans will be randomized to receive AboutFace versus eUC. All Veterans will receive standard PTSD educational materials, and half will also be randomly assigned to receive AboutFace. Comparisons will be made across indices of treatment engagement [i.e., initiated treatment (yes/no), total number of sessions completed;]; changes in stigma and attitudes toward seeking mental health treatment; and changes in PTSD symptoms and quality of life. Veterans will be assessed on these indices at baseline, 1-month, 3-month, and 6-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AboutFace | Active Comparator | Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD |
|
| Enhanced Usual Care (eUC) | Placebo Comparator | Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AboutFace | Behavioral | AboutFace is an online peer-to-peer digital storytelling resource for Veterans with PTSD. Veterans will have access to AboutFace while they are enrolled in PTSD specialty care through the Charleston PCT. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Treatment Engagement (Yes/no) | Dichotomous yes/no variable for whether or not a participant started at least one session of PTSD specialty care within 60 days of baseline. This measure indicates the number of participants who attended a minimum of one session of a PTSD treatment within 60 days of the initial baseline administration. | Baseline up to 60 days |
| Total Number of PTSD Treatment Sessions | Total number of PTSD treatment sessions completed from baseline to 60 days | Baseline up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Checklist-5 (PCL-5) | The PCL is a 20-item self-report measure of PTSD severity. The self-report rating scale is 0-4 for each symptom: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." Total score can range from 0-80. | 6 months |
| Endorsed and Anticipated Stigma Inventory (EASI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anouk L. Grubaugh, PhD MA BS | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28239485 | Result | Bunnell BE, Davidson TM, Hamblen JL, Cook DL, Grubaugh AL, Lozano BE, Tuerk PW, Ruggiero KJ. Protocol for the evaluation of a digital storytelling approach to address stigma and improve readiness to seek services among veterans. Pilot Feasibility Stud. 2017 Feb 17;3:7. doi: 10.1186/s40814-017-0121-3. eCollection 2017. | |
| 29746232 | Result |
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Veterans will be referred following a PTSD evaluation through the Charleston VAMC PTSD Clinic Team (PCT) and Telehealth Programs and recommended for PTSD specialty care through the clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | AboutFace | Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: AboutFace is an online peer-to-peer digital storytelling resource for Veterans with PTSD. Veterans will have access to AboutFace while they are enrolled in PTSD specialty care through the Charleston PCT. |
| FG001 | Enhanced Usual Care (eUC) | Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed 1 Month Up |
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| Completed 3 Month Follow up |
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| Completed 6 Month Follow |
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| ID | Title | Description |
|---|---|---|
| BG000 | AboutFace | Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: AboutFace is an online peer-to-peer digital storytelling resource for Veterans with PTSD. Veterans will have access to AboutFace while they are enrolled in PTSD specialty care through the Charleston PCT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Treatment Engagement (Yes/no) | Dichotomous yes/no variable for whether or not a participant started at least one session of PTSD specialty care within 60 days of baseline. This measure indicates the number of participants who attended a minimum of one session of a PTSD treatment within 60 days of the initial baseline administration. | Posted | Count of Participants | Participants | Baseline up to 60 days |
|
Adverse event data was collected throughout entirety of study and reported at time of event. Participant charts were reviewed at each assessment point; 1 month, 3 month and 6 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AboutFace | Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: AboutFace is an online peer-to-peer digital storytelling resource for Veterans with PTSD. Veterans will have access to AboutFace while they are enrolled in PTSD specialty care through the Charleston PCT. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Ralph H. Johnson VA Medical Center | 843-301-9917 | sarah.szafranski@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2018 | Mar 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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376 Veterans who are referred for a PTSD evaluation through the Charleston VAMC PTSD Clinic Team (PCT) and Telehealth Programs and are recommended for PTSD specialty care will be randomized to receive an online peer-to-peer digital storytelling resource [AboutFace] or an educational brochure for PTSD [enhanced Usual Care; eUC]
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Post-treatment assessors and a co-investigator in charge of randomization will be blind to condition assignment
| Enhanced Usual Care (eUC) | Other | Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT. |
|
EASI assesses different dimensions of stigma-related beliefs about mental health among military personnel and Veterans. It measures 5 dimensions: beliefs about mental illness, beliefs about mental health treatment, beliefs about seeking treatment, concerns about stigma from loved ones, and concerns about stigma in the workplace. Scores range from 40- 200. Higher scores are indicative of greater stigma; thus improvement is evident in reduction of scores/reduction of stigma in mental health. |
| 6 months |
| Patient Health Questionnaire (PHQ-8) | The PHQ-8 is a brief questionnaire that scores each of the 8 Diagnostic Statistical Manual (DSM)-IV criteria for depression as "0" (not at all) to "3" (nearly every day) with higher total scores indicating greater symptoms. Scores range from 0-24. PHQ-8 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively. | 6 months |
| Quality of Life Index (QLI) | The QLI is a 2-part, 33-item self-report measure of life satisfaction and importance regarding various aspects of life with higher scores representing better outcomes. Scores range from 0-30. An increase in score would represent an increase in life satisfaction. | 6 months |
| Hamblen JL, Grubaugh AL, Davidson TM, Borkman AL, Bunnell BE, Ruggiero KJ. An Online Peer Educational Campaign to Reduce Stigma and Improve Help Seeking in Veterans with Posttraumatic Stress Disorder. Telemed J E Health. 2019 Jan;25(1):41-47. doi: 10.1089/tmj.2017.0305. Epub 2018 May 10. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Enhanced Usual Care (eUC) |
Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Missing one data point from Control | Count of Participants | Participants |
|
| Race (NIH/OMB) | Unknown category captures Hispanic and those who stated "other" | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Marital Status | One data point missing from Marital status | Count of Participants | Participants |
|
| Employment Status | 2 data points missing from Baseline assessment | Count of Participants | Participants |
|
| Combat Veteran status | 3 data points missing for Combat Era | Count of Participants | Participants |
|
Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT. |
|
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| Primary | Total Number of PTSD Treatment Sessions | Total number of PTSD treatment sessions completed from baseline to 60 days | Posted | Mean | Standard Deviation | Number of sessions | Baseline up to 60 days |
|
|
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| Secondary | Posttraumatic Stress Disorder Checklist-5 (PCL-5) | The PCL is a 20-item self-report measure of PTSD severity. The self-report rating scale is 0-4 for each symptom: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." Total score can range from 0-80. | The overall number of participants analyzed is inconsistent with the total number of participants enrolled in each condition because these results are reflective of the 6 month assessment point. These numbers reflect the number of participants who completed this measure at the 6 month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Endorsed and Anticipated Stigma Inventory (EASI) | EASI assesses different dimensions of stigma-related beliefs about mental health among military personnel and Veterans. It measures 5 dimensions: beliefs about mental illness, beliefs about mental health treatment, beliefs about seeking treatment, concerns about stigma from loved ones, and concerns about stigma in the workplace. Scores range from 40- 200. Higher scores are indicative of greater stigma; thus improvement is evident in reduction of scores/reduction of stigma in mental health. | The overall number of participants analyzed is inconsistent with the total number of participants enrolled in each condition because these results are reflective of the 6 month assessment point. These numbers reflect the number of participants who completed this measure at the 6 month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-8) | The PHQ-8 is a brief questionnaire that scores each of the 8 Diagnostic Statistical Manual (DSM)-IV criteria for depression as "0" (not at all) to "3" (nearly every day) with higher total scores indicating greater symptoms. Scores range from 0-24. PHQ-8 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively. | The overall number of participants analyzed is inconsistent with the total number of participants enrolled in each condition because these results are reflective of the 6 month assessment point. These numbers reflect the number of participants who completed this measure at the 6 month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Quality of Life Index (QLI) | The QLI is a 2-part, 33-item self-report measure of life satisfaction and importance regarding various aspects of life with higher scores representing better outcomes. Scores range from 0-30. An increase in score would represent an increase in life satisfaction. | The overall number of participants analyzed is inconsistent with the total number of participants enrolled in each condition because these results are reflective of the 6 month assessment point. These numbers reflect the number of participants who completed this measure at the 6 month assessment. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
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|
| 0 |
| 165 |
| 0 |
| 165 |
| 3 |
| 165 |
| EG001 | Enhanced Usual Care (eUC) | Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT. | 1 | 165 | 0 | 165 | 3 | 165 |
| Incarceration | Social circumstances | Systematic Assessment |
|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Divorced |
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| Never Married |
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| Widowed |
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| Other |
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| Part Time |
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| Student |
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| Unemployed |
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| Vietnam |
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| Desert Storm |
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| OEF/OIF |
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| Other |
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