Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02486692
Collaborator
(none)
60
1
2
20
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: AboutFace Website
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pilot Evaluation of AboutFace: A Novel Peer Education Resource for Veterans
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase II- Experimental Group

Participants were provided with instructions and a web link for accessing the AboutFace website after the baseline assessment.

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

No Intervention: Phase II- Usual Care Group

Participants were provided with instructions and a web link for accessing some online PTSD education materials after the baseline assessment.

Outcome Measures

Primary Outcome Measures

  1. Endorsed and Anticipated Stigma Inventory (EASI) [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.

  2. PTSD Checklist (PCL-V) [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.

  3. PTSD Treatment Initiators [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Must be 18 years of age

  • Recommended for PTSD treatment following evaluation

  • Internet access

  • English Speaking

Exclusion Criteria:
  • Minors under the age of 18

  • Non-Veterans

  • Negative for PTSD

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina United States 29401-5799

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Kenneth J Ruggiero, PhD MA BA, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02486692
Other Study ID Numbers:
  • PPO 14-360
First Posted:
Jul 1, 2015
Last Update Posted:
Jun 5, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by VA Office of Research and Development

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Phase II-Experimental Phase II- Usual Care Condition
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only
Period Title: Overall Study
STARTED 30 30
COMPLETED 26 23
NOT COMPLETED 4 7

Baseline Characteristics

Arm/Group Title Phase II-Experimental Phase II- Usual Care Condition Total
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only Total of all reporting groups
Overall Participants 30 30 60
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
28
93.3%
27
90%
55
91.7%
>=65 years
2
6.7%
3
10%
5
8.3%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
42.27
42.13
42.20
Sex: Female, Male (Count of Participants)
Female
11
36.7%
6
20%
17
28.3%
Male
19
63.3%
24
80%
43
71.7%
Region of Enrollment (Count of Participants)
United States
30
100%
30
100%
60
100%

Outcome Measures

1. Primary Outcome
Title Endorsed and Anticipated Stigma Inventory (EASI)
Description 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.
Time Frame pre-treatment (baseline) & post-treatment (two-week) assessment

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Phase II-Experimental Phase II- Usual Care Condition
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only
Measure Participants 26 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)
2. Primary Outcome
Title PTSD Checklist (PCL-V)
Description 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.
Time Frame pre-treatment (baseline) & post-treatment (2-week) assessment

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Phase II-Experimental Phase II- Usual Care Condition
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only
Measure Participants 26 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)
3. Primary Outcome
Title PTSD Treatment Initiators
Description 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.
Time Frame two weeks post assessment

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Phase II-Experimental Phase II- Usual Care Condition
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only
Measure Participants 26 22
Count of Participants [Participants]
20
66.7%
15
50%

Adverse Events

Time Frame Up to two weeks for Phase II participants (baseline to 2 weeks post assessment).
Adverse Event Reporting Description No adverse events were reported in Phase I. Participation involved a single visit.
Arm/Group Title Phase II- Experimental Phase II- Usual Care Condition
Arm/Group Description Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD. Education and Print materials only
All Cause Mortality
Phase II- Experimental Phase II- Usual Care Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)
Serious Adverse Events
Phase II- Experimental Phase II- Usual Care Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)
Other (Not Including Serious) Adverse Events
Phase II- Experimental Phase II- Usual Care Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Anouk Grubaugh
Organization Ralph H. Johnson VAMC
Phone 843-532-6672
Email grubaugh@musc.edu
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02486692
Other Study ID Numbers:
  • PPO 14-360
First Posted:
Jul 1, 2015
Last Update Posted:
Jun 5, 2019
Last Verified:
May 1, 2019