Posttraumatic Stress Disorder, PTSD
Conditions
Keywords
PTSD, peer resource, Veterans, web-based intervention, digital story telling
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAboutFace
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.
OTHEREnhanced 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Post-treatment assessors and a co-investigator in charge of randomization will be blind to condition assignment
Intervention model description
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 \[enhanced Usual Care; eUC\]
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans must be referred for a PTSD evaluation through the Charleston VAMC PTSD Clinic Team (PCT) and Telehealth Programs and recommended for PTSD specialty care through the clinic.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Treatment Engagement (Yes/no) | Baseline up to 60 days | 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. |
| Total Number of PTSD Treatment Sessions | Baseline up to 60 days | Total number of PTSD treatment sessions completed from baseline to 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist-5 (PCL-5) | 6 months | 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. |
| Endorsed and Anticipated Stigma Inventory (EASI) | 6 months | 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. |
| Patient Health Questionnaire (PHQ-8) | 6 months | 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. |
| Quality of Life Index (QLI) | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 165 |
| 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. | 165 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed 1 Month Up | Lost to Follow-up | 59 | 58 |
| Completed 3 Month Follow up | Death | 0 | 1 |
| Completed 3 Month Follow up | Lost to Follow-up | 64 | 59 |
| Completed 6 Month Follow | Lost to Follow-up | 66 | 70 |
Baseline characteristics
| Characteristic | AboutFace | Enhanced Usual Care (eUC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 4 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 157 Participants | 161 Participants | 318 Participants |
| Age, Continuous | 44.39 years STANDARD_DEVIATION 11.57 | 43.17 years STANDARD_DEVIATION 11.78 | 43.78 years STANDARD_DEVIATION 11.68 |
| Combat Veteran status Desert Storm | 17 Participants | 10 Participants | 27 Participants |
| Combat Veteran status No Combat | 48 Participants | 52 Participants | 100 Participants |
| Combat Veteran status OEF/OIF | 92 Participants | 93 Participants | 185 Participants |
| Combat Veteran status Other | 2 Participants | 4 Participants | 6 Participants |
| Combat Veteran status Vietnam | 5 Participants | 2 Participants | 7 Participants |
| Combat Veteran status WWII/Korea | 1 Participants | 1 Participants | 2 Participants |
| Employment Status Full Time | 79 Participants | 85 Participants | 164 Participants |
| Employment Status Part Time | 25 Participants | 17 Participants | 42 Participants |
| Employment Status Retired | 22 Participants | 18 Participants | 40 Participants |
| Employment Status Student | 15 Participants | 15 Participants | 30 Participants |
| Employment Status Unemployed | 24 Participants | 28 Participants | 52 Participants |
| Marital Status Divorced | 29 Participants | 29 Participants | 58 Participants |
| Marital Status Married | 106 Participants | 104 Participants | 210 Participants |
| Marital Status Never Married | 16 Participants | 22 Participants | 38 Participants |
| Marital Status Other | 6 Participants | 5 Participants | 11 Participants |
| Marital Status Separated | 6 Participants | 3 Participants | 9 Participants |
| Marital Status Widowed | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 86 Participants | 162 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) White | 78 Participants | 68 Participants | 146 Participants |
| Region of Enrollment United States | 165 Participants | 165 Participants | 330 Participants |
| Sex: Female, Male Female | 57 Participants | 46 Participants | 103 Participants |
| Sex: Female, Male Male | 108 Participants | 118 Participants | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 1 / 165 |
| other Total, other adverse events | 3 / 165 | 3 / 165 |
| serious Total, serious adverse events | 0 / 165 | 0 / 165 |
Outcome results
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.
Time frame: Baseline up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AboutFace | PTSD Treatment Engagement (Yes/no) | 137 Participants |
| Enhanced Usual Care (eUC) | PTSD Treatment Engagement (Yes/no) | 132 Participants |
Primary
Total Number of PTSD Treatment Sessions
Total number of PTSD treatment sessions completed from baseline to 60 days
Time frame: Baseline up to 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AboutFace | Total Number of PTSD Treatment Sessions | 8.5 Number of sessions | Standard Deviation 4.8 |
| Enhanced Usual Care (eUC) | Total Number of PTSD Treatment Sessions | 8.5 Number of sessions | Standard Deviation 4.4 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AboutFace | Endorsed and Anticipated Stigma Inventory (EASI) | 99.33 score on a scale | Standard Deviation 30.97 |
| Enhanced Usual Care (eUC) | Endorsed and Anticipated Stigma Inventory (EASI) | 98.76 score on a scale | Standard Deviation 30.45 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AboutFace | Patient Health Questionnaire (PHQ-8) | 15.3 score on a scale | Standard Deviation 5.7 |
| Enhanced Usual Care (eUC) | Patient Health Questionnaire (PHQ-8) | 14.5 score on a scale | Standard Deviation 6.3 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AboutFace | Posttraumatic Stress Disorder Checklist-5 (PCL-5) | 49.9 score on a scale | Standard Deviation 16.5 |
| Enhanced Usual Care (eUC) | Posttraumatic Stress Disorder Checklist-5 (PCL-5) | 46.9 score on a scale | Standard Deviation 19.7 |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AboutFace | Quality of Life Index (QLI) | 15.5 score on a scale | Standard Deviation 2.6 |
| Enhanced Usual Care (eUC) | Quality of Life Index (QLI) | 15.5 score on a scale | Standard Deviation 2.5 |