PTSDNCT02486692

Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans

A study testing AboutFace Website in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the AboutFace peer education website for the purpose of reducing stigma and improving attitudes toward seeking mental health services among Veterans. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: PTSD
What is being tested?: AboutFace Website
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Dec 2016
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must be 18 years of age
Recommended for PTSD treatment following evaluation
Internet access
English Speaking

Who cannot join

Minors under the age of 18
Non-Veterans
Negative for PTSD

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

Other trials in United States

About this study

Official title: Pilot Evaluation of AboutFace: A Novel Peer Education Resource for Veterans

The purpose of this study is to evaluate the AboutFace peer education website for the purpose of reducing stigma and improving attitudes toward seeking mental health services among Veterans.

Read the detailed description

Research suggests that at least 1 in 10 Veterans will meet criteria for posttraumatic stress disorder (PTSD) related to their military experience. Treatment is widely available to Veterans with PTSD, and national dissemination initiatives have increased Veterans' access to best practice interventions. However, treatment seeking remains strikingly low among Veterans with PTSD. In fact, most Veterans with PTSD do not seek mental health services due to perceived stigma and other associated barriers. The National Center for PTSD recently developed and launched AboutFace, a peer education resource for Veterans. The investigators of this study believe that AboutFace has tremendous potential to reduce stigma and improve attitudes toward seeking mental health services among Veterans. However, it has not yet been evaluated. Investigators have partnered with the National Center for PTSD to launch this mixed methods pilot evaluation of AboutFace. There will be two phases to this study. During Phase I- Usability, 20 Veterans will be recruited to participate in individual interviews during which they will be asked to describe the ease of use of the AboutFace website for the researchers. During Phase II- Feasibility, 60 Veterans will be randomized to one of two conditions- About Face or Usual Care. All participants will complete several brief assessments measuring PTSD symptoms and attitudes toward seeking mental health services. Participants will then be randomized to either receive a link to the About Face website or to receive a link to a general online brochure about PTSD. After two weeks, participants will complete the assessment measures once again to determine any changes in attitudes toward seeking mental health services and potential changes in PTSD symptoms.

Conditions: PTSD
Being tested: AboutFace Website
Keywords: Mental Health, PTSD, Stigma, Peer Education, Web Education, Self Help
Medical subject headings: Stress Disorders, Post-Traumatic, Psychological Well-Being, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AboutFace WebsiteOther
AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and different treatments for PTSD.

Study groups in NCT02486692
Study group	Role	What they receive
Phase II- Experimental Group	Experimental	Participants were provided with instructions and a web link for accessing the AboutFace website after the baseline assessment. Receives: Other: AboutFace Website
Phase II- Usual Care Group	No intervention	Participants were provided with instructions and a web link for accessing some online PTSD education materials after the baseline assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Endorsed and Anticipated Stigma Inventory (EASI)
THE EASI assesses for perceptions of treatment effectiveness, stigma, and external barriers to treatment seeking. Answers are ranked from 1 to 5 with 1 being "Strongly Disagree" and 5 being "Strongly Agree" and higher scores are indicative of greater stigma. Total scores can range from 40 to 190.
Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
Measured: pre-treatment (baseline) & post-treatment (two-week) assessment
PTSD Checklist (PCL-V)
The PCL-V is a 20-item self-report measure that assesses PTSD severity. Individual item responses can range from 0-4 with 0 being "Not At All" and 4 being "Extremely" and total scores can range from 0 to 80. Higher numbers on the PCL-V are indicative of greater PTSD severity.
Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
Measured: pre-treatment (baseline) & post-treatment (2-week) assessment
PTSD Treatment Initiators
percentage/rate of PTSD treatment initiation at post assessment (2-weeks) Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
Measured: two weeks post assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Dec 2016

First posted1 Jul 2015 (estimated)
Study startApr 2015
Primary completionSep 2016
Study completionDec 2016

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 (3)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
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02486692
Sponsor's protocol ID: PPO 14-360
Status last verified: May 2019
First submitted: 16 Jun 2015
Last updated: 5 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kreuze E, Jenkins C, Gregoski M, York J, Mueller M, Lamis DA, Ruggiero KJ. Technology-enhanced suicide prevention interventions: A systematic review. J Telemed Telecare. 2017 Jul;23(6):605-617. doi: 10.1177/1357633X16657928. Epub 2016 Jul 3.
PubMed 27377792
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.
PubMed 29746232
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 28239485

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Evaluation of AboutFace: A Novel Peer Education Resource for Veterans
ClinicalTrials.gov ID: NCT02486692
Acronym / sponsor ID: PPO 14-360
Conditions: PTSD
Keywords: Mental Health, PTSD, Stigma, Peer Education, Web Education, Self Help
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Apr 2015
Primary completion: Sep 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 1 Jul 2015 (estimated)
Results: Posted 6 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the AboutFace peer education website for the purpose of reducing stigma and improving attitudes toward seeking mental health services among Veterans.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase II- Experimental Group	Experimental	Other: AboutFace WebsiteParticipants were provided with instructions and a web link for accessing the AboutFace website after the baseline assessment.
Phase II- Usual Care Group	No intervention	–Participants were provided with instructions and a web link for accessing some online PTSD education materials after the baseline assessment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must be 18 years of age
Recommended for PTSD treatment following evaluation
Internet access
English Speaking

Key exclusion criteria (3 listed)

Minors under the age of 18
Non-Veterans
Negative for PTSD

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
AboutFace WebsiteAboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and different treatments for PTSD.	Other	Phase II- Experimental Group

Primary outcome

Endorsed and Anticipated Stigma Inventory (EASI)
Time frame: pre-treatment (baseline) & post-treatment (two-week) assessment
THE EASI assesses for perceptions of treatment effectiveness, stigma, and external barriers to treatment seeking. Answers are ranked from 1 to 5 with 1 being "Strongly Disagree" and 5 being "Strongly Agree" and higher scores are indicative of greater stigma. Total scores can range from 40 to 190. Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
PTSD Checklist (PCL-V)
Time frame: pre-treatment (baseline) & post-treatment (2-week) assessment
The PCL-V is a 20-item self-report measure that assesses PTSD severity. Individual item responses can range from 0-4 with 0 being "Not At All" and 4 being "Extremely" and total scores can range from 0 to 80. Higher numbers on the PCL-V are indicative of greater PTSD severity. Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.
PTSD Treatment Initiators
Time frame: two weeks post assessment
percentage/rate of PTSD treatment initiation at post assessment (2-weeks) Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.

Results and safety

Results posted to the registry on 6 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase II-Experimental	30	26
Phase II- Usual Care Condition	30	23

Primary outcome: Endorsed and Anticipated Stigma Inventory (EASI)

Time frame: pre-treatment (baseline) & post-treatment (two-week) assessment. Mean (Standard Deviation). Unit: units on a scale

Measure	Phase II-Experimental n = 26	Phase II- Usual Care Condition n = 22
pre-treatment (baseline) mean	57.9 (27.2)	62.3 (31.4)
post-treatment (2-week) mean	57.5 (33.1)	54.1 (30.7)

Population analysed: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access website portal to obtain their randomization assignment. The EASI was also missing for 1 participant at post.

Primary outcome: PTSD Checklist (PCL-V)

Time frame: pre-treatment (baseline) & post-treatment (2-week) assessment. Mean (Standard Deviation). Unit: units on a scale

Measure	Phase II-Experimental n = 26	Phase II- Usual Care Condition n = 23
pre-treatment (baseline) mean (sd)	51.1 (10.6)	52.1 (11.4)
post-treatment (2-week) mean (sd)	49.4 (9.7)	49.5 (12.5)

Population analysed: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment.

Primary outcome: PTSD Treatment Initiators

Time frame: two weeks post assessment. Count of participants. Unit: Participants

Measure	Phase II-Experimental n = 26	Phase II- Usual Care Condition n = 22
Value	20	15

Population analysed: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment. Data was also missing for 1 participant at post.

Adverse events

Time frame: Up to two weeks for Phase II participants (baseline to 2 weeks post assessment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase II- Experimental	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Phase II- Usual Care Condition	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27377792Kreuze E, Jenkins C, Gregoski M, York J, Mueller M, Lamis DA, Ruggiero KJ. Technology-enhanced suicide prevention interventions: A systematic review. J Telemed Telecare. 2017 Jul;23(6):605-617. doi: 10.1177/1357633X16657928. Epub 2016 Jul 3.
Derived from this study: 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.
Derived from this study: 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.
Individual participant dataSharing planned: No

Related trials for PTSD

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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.

Kenneth J Ruggiero, PhD MA BA 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 Website in people with PTSD, 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 4 inclusion and 3 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 5 Jun 2019. 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. 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 6 May 2019). 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?

Endorsed and Anticipated Stigma Inventory (EASI) (time frame: pre-treatment (baseline) & post-treatment (two-week) assessment). The study lists 3 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 NCT02486692, which also lists 3 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 5 Jun 2019.