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The Use of a Novel Peer Education Program for Improving PTSD Treatment Engagement Among Veterans (AboutFace)

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ClinicalTrials.gov Identifier: NCT03521999
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 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.

Condition or disease Intervention/treatment Phase
PTSD Posttraumatic Stress Disorder Behavioral: AboutFace Other: Enhanced Usual Care (eUC) Not Applicable

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 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 #PPO 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 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. Thematic interviews will be conducted with 20-30 VA PTSD Clinical Team Directors from a diverse range of PTSD clinics (i.e., ranging in size, location, and practice) to inform future implementation and dissemination initiatives.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel 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]
Masking: Single (Outcomes Assessor)
Masking Description: Post-treatment assessors and a co-investigator in charge of randomization will be blind to condition assignment
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial of AboutFace: A Novel Video Storytelling Resource to Improve Access, Engagement, and Utilization of Mental Health Treatment Among Veterans With PTSD
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Active Comparator: AboutFace
Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD
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.

Placebo Comparator: Enhanced Usual Care (eUC)
Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD
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.




Primary Outcome Measures :
  1. PTSD treatment engagement (yes/no) [ Time Frame: Baseline up to 6 months ]
    Dichotomous yes/no variable for whether or not a participant started at least one session of PTSD specialty care.

  2. Total number of PTSD treatment sessions [ Time Frame: Baseline up to 6 months ]
    Total number of PTSD treatment sessions completed from baseline to 6 months.


Secondary Outcome Measures :
  1. Posttraumatic Stress Disorder Checklist-5 (PCL-5) [ Time Frame: change from baseline up to 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.

  2. Endorsed and Anticipated Stigma Inventory (EASI) [ Time Frame: change from baseline up to 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. Higher scores indicative of greater stigma.

  3. Patient Health Questionnaire (PHQ-9) [ Time Frame: change from baseline up to 6 months ]
    The PHQ-9 is a brief questionnaire that scores each of the 9 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 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.

  4. Quality of Life Index (QLI) [ Time Frame: change from baseline up to 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521999


Contacts
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Contact: Anouk L Grubaugh, PhD MA BS (843) 789-6664 Anouk.Grubaugh@va.gov

Locations
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United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Sarah A Jackson, BA MA    843-789-6700    sarah.jackson@va.gov   
Principal Investigator: Anouk L. Grubaugh, PhD MA BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Anouk L. Grubaugh, PhD MA BS Ralph H. Johnson VA Medical Center, Charleston, SC

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03521999     History of Changes
Other Study ID Numbers: IIR 17-123
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
peer resource
Veterans
web-based intervention
digital story telling

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders