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NCT03521999: AboutFace

The Use of a Novel Peer Education Program for Improving PTSD Treatment Engagement Among Veterans

Completed NA Results posted Last updated 14 June 2024
What this trial tests

NA trial testing AboutFace in PTSD in 330 participants. Completed in 30 September 2022.

Timeline
1 August 2018
Primary endpoint
30 August 2022
30 September 2022

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment330
Start date1 August 2018
Primary completion30 August 2022
Estimated completion30 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with PTSD or Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PTSD Treatment Engagement (Yes/no) Primary · 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.

GroupValue95% CI
AboutFace137
Enhanced Usual Care (eUC)132
Total Number of PTSD Treatment Sessions Primary · Baseline up to 60 days

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

GroupValue95% CI
AboutFace8.5± 4.8
Enhanced Usual Care (eUC)8.5± 4.4
Posttraumatic Stress Disorder Checklist-5 (PCL-5) Secondary · 6 months

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.

GroupValue95% CI
AboutFace49.9± 16.5
Enhanced Usual Care (eUC)46.9± 19.7
Endorsed and Anticipated Stigma Inventory (EASI) Secondary · 6 months

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.

GroupValue95% CI
AboutFace99.33± 30.97
Enhanced Usual Care (eUC)98.76± 30.45
Patient Health Questionnaire (PHQ-8) Secondary · 6 months

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.

GroupValue95% CI
AboutFace15.3± 5.7
Enhanced Usual Care (eUC)14.5± 6.3
Quality of Life Index (QLI) Secondary · 6 months

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.

GroupValue95% CI
AboutFace15.5± 2.6
Enhanced Usual Care (eUC)15.5± 2.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected throughout entirety of study and reported at time of event. Participant charts were reviewed at each assessment point; 1 month, 3 month and 6 month.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AboutFace
Serious: 0/165 (0%)
Deaths: 0/165
Enhanced Usual Care (eUC)
Serious: 0/165 (0%)
Deaths: 1/165
Other adverse events (2 terms — click to expand)

ReactionSystemAboutFaceEnhanced Usual Care (eUC)
InpatientPsychiatric disorders
IncarcerationSocial circumstances

Data from ClinicalTrials.gov NCT03521999 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for PTSD

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03521999.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing