NCT03521999

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

April 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

April 26, 2018

Results QC Date

April 5, 2023

Last Update Submit

January 23, 2024

Conditions

Keywords

PTSDpeer resourceVeteransweb-based interventiondigital story telling

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline up to 60 days

  • Total Number of PTSD Treatment Sessions

    Total number of PTSD treatment sessions completed from baseline to 60 days

    Baseline up to 60 days

Secondary Outcomes (4)

  • Posttraumatic Stress Disorder Checklist-5 (PCL-5)

    6 months

  • Endorsed and Anticipated Stigma Inventory (EASI)

    6 months

  • Patient Health Questionnaire (PHQ-8)

    6 months

  • Quality of Life Index (QLI)

    6 months

Study Arms (2)

AboutFace

ACTIVE COMPARATOR

Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD

Behavioral: AboutFace

Enhanced Usual Care (eUC)

PLACEBO COMPARATOR

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

Other: Enhanced Usual Care (eUC)

Interventions

AboutFaceBEHAVIORAL

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.

AboutFace

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.

Enhanced Usual Care (eUC)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • None

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 (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Research Coordinator
Organization
Ralph H. Johnson VA Medical Center

Study Officials

  • Anouk L. Grubaugh, PhD MA BS

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Post-treatment assessors and a co-investigator in charge of randomization will be blind to condition assignment
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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 \[enhanced Usual Care; eUC\]
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 11, 2018

Study Start

August 1, 2018

Primary Completion

August 30, 2022

Study Completion

September 30, 2022

Last Updated

June 14, 2024

Results First Posted

June 14, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations