NCT02486692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2019

Completed
Last Updated

June 5, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

June 16, 2015

Results QC Date

September 21, 2017

Last Update Submit

May 22, 2019

Conditions

Keywords

Mental HealthPTSDStigmaPeer EducationWeb EducationSelf Help

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    two weeks post assessment

Study Arms (2)

Phase II- Experimental Group

EXPERIMENTAL

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

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.

Interventions

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

Phase II- Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPsychological Well-BeingSocial Stigma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal SatisfactionBehaviorSocial Behavior

Results Point of Contact

Title
Anouk Grubaugh
Organization
Ralph H. Johnson VAMC

Study Officials

  • Kenneth J Ruggiero, PhD MA BA

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 1, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

June 5, 2019

Results First Posted

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations