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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03521999
Other study ID # IIR 17-123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date September 30, 2022

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date September 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
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.
Other:
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.

Locations

Country Name City State
United States Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 20 — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Baseline up to 60 days
Primary Total Number of PTSD Treatment Sessions Total number of PTSD treatment sessions completed from baseline to 60 days Baseline up to 60 days
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. 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. 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. 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. 6 months
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