PTSDAboutFaceNCT03521999
The Use of a Novel Peer Education Program for Improving PTSD Treatment Engagement Among Veterans
A study testing AboutFace in people with PTSD and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Posttraumatic Stress Disorder
- What is being tested?
- AboutFace
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
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
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.
Read the 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.
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Being tested
- AboutFace, Enhanced Usual Care (eUC)
- Keywords
- PTSD, peer resource, Veterans, web-based intervention, digital story telling
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AboutFaceBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| AboutFace | Active comparator | Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD Receives: Behavioral: AboutFace |
| Enhanced Usual Care (eUC) | Placebo comparator | Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Receives: Other: Enhanced Usual Care (eUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 60 days
Total Number of PTSD Treatment Sessions
Total number of PTSD treatment sessions completed from baseline to 60 days
Measured: Baseline up to 60 days
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Aug 2018
- Primary completion30 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anouk L. Grubaugh, PhD MA BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521999
- Sponsor's protocol ID
- IIR 17-123
- Acronym
- AboutFace
- Status last verified
- Jan 2024
- First submitted
- 26 Apr 2018
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28239485Hamblen 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.
PubMed 29746232
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03521999
- Acronym / sponsor ID
- AboutFace / IIR 17-123
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Keywords
- PTSD, peer resource, Veterans, web-based intervention, digital story telling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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]
| Arm | Type | Receives |
|---|---|---|
| AboutFace | Active comparator | Behavioral: AboutFaceVeterans 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 | Other: Enhanced Usual Care (eUC)Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AboutFaceAboutFace 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. | Behavioural | AboutFace |
| 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. | Other | Enhanced Usual Care (eUC) |
Primary outcome
PTSD Treatment Engagement (Yes/no)
Time frame: 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
Time frame: Baseline up to 60 days
Total number of PTSD treatment sessions completed from baseline to 60 days
4 secondary outcomes
Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Time frame: 6 months
Endorsed and Anticipated Stigma Inventory (EASI)
Time frame: 6 months
Patient Health Questionnaire (PHQ-8)
Time frame: 6 months
Quality of Life Index (QLI)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28239485Bunnell 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.
- Results publication: PubMed 29746232Hamblen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anouk L. Grubaugh, PhD MA BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AboutFace in people with PTSD and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Treatment Engagement (Yes/no) (time frame: Baseline up to 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521999, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.