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.
Group
Value
95% CI
AboutFace
137
Enhanced Usual Care (eUC)
132
Total Number of PTSD Treatment SessionsPrimary· Baseline up to 60 days
Total number of PTSD treatment sessions completed from baseline to 60 days
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.
Group
Value
95% CI
AboutFace
49.9
± 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.
Group
Value
95% CI
AboutFace
99.33
± 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.
Group
Value
95% CI
AboutFace
15.3
± 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.
Group
Value
95% CI
AboutFace
15.5
± 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.
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.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 14 June 2024
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.