Trial Outcomes & Findings for The Use of a Novel Peer Education Program for Improving PTSD Treatment Engagement Among Veterans (NCT NCT03521999)

NCT ID: NCT03521999

Last Updated: 2024-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

330 participants

Primary outcome timeframe

Baseline up to 60 days

Results posted on

2024-06-14

Participant Flow

Veterans will be referred following a PTSD evaluation through the Charleston VAMC PTSD Clinic Team (PCT) and Telehealth Programs and recommended for PTSD specialty care through the clinic

Participant milestones

Participant milestones
Measure	AboutFace Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Completed 1 Month Up STARTED	165	165
Completed 1 Month Up COMPLETED	106	107
Completed 1 Month Up NOT COMPLETED	59	58
Completed 3 Month Follow up STARTED	165	165
Completed 3 Month Follow up COMPLETED	101	105
Completed 3 Month Follow up NOT COMPLETED	64	60
Completed 6 Month Follow STARTED	165	164
Completed 6 Month Follow COMPLETED	99	94
Completed 6 Month Follow NOT COMPLETED	66	70

Reasons for withdrawal

Reasons for withdrawal
Measure	AboutFace Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Completed 1 Month Up Lost to Follow-up	59	58
Completed 3 Month Follow up Lost to Follow-up	64	59
Completed 3 Month Follow up Death	0	1
Completed 6 Month Follow Lost to Follow-up	66	70

Baseline Characteristics

Missing one data point from Control

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline up to 60 days

Outcome measures

Outcome measures
Measure	AboutFace n=165 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=165 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
PTSD Treatment Engagement (Yes/no)	137 Participants	132 Participants

PRIMARY outcome

Timeframe: Baseline up to 60 days

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

Outcome measures

Outcome measures
Measure	AboutFace n=165 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=165 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Total Number of PTSD Treatment Sessions	8.5 Number of sessions Standard Deviation 4.8	8.5 Number of sessions Standard Deviation 4.4

SECONDARY outcome

Timeframe: 6 months

Population: The overall number of participants analyzed is inconsistent with the total number of participants enrolled in each condition because these results are reflective of the 6 month assessment point. These numbers reflect the number of participants who completed this measure at the 6 month assessment.

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.

Outcome measures

Outcome measures
Measure	AboutFace n=99 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=91 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Posttraumatic Stress Disorder Checklist-5 (PCL-5)	49.9 score on a scale Standard Deviation 16.5	46.9 score on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AboutFace n=99 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=91 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Endorsed and Anticipated Stigma Inventory (EASI)	99.33 score on a scale Standard Deviation 30.97	98.76 score on a scale Standard Deviation 30.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AboutFace n=99 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=91 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Patient Health Questionnaire (PHQ-8)	15.3 score on a scale Standard Deviation 5.7	14.5 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AboutFace n=98 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=90 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Quality of Life Index (QLI)	15.5 score on a scale Standard Deviation 2.6	15.5 score on a scale Standard Deviation 2.5

Adverse Events

AboutFace

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Enhanced Usual Care (eUC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AboutFace n=165 participants at risk Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=165 participants at risk Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.
Psychiatric disorders Inpatient	1.2% 2/165 • 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.	1.8% 3/165 • 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.
Social circumstances Incarceration	0.61% 1/165 • 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.	0.00% 0/165 • 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.

Additional Information

Research Coordinator

Ralph H. Johnson VA Medical Center

Phone: 843-301-9917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AboutFace n=165 Participants Veterans in the AboutFACe arm will receive access to an online peer-to-peer digital storytelling resource for Veterans with PTSD AboutFace: 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.	Enhanced Usual Care (eUC) n=165 Participants Veterans in the Enhanced Usual Care (eUC) arm will receive an education brochure for PTSD Enhanced Usual Care (eUC): 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.	Total n=330 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=165 Participants	0 Participants n=165 Participants	0 Participants n=330 Participants
Age, Categorical Between 18 and 65 years	157 Participants n=165 Participants	161 Participants n=165 Participants	318 Participants n=330 Participants
Age, Categorical >=65 years	8 Participants n=165 Participants	4 Participants n=165 Participants	12 Participants n=330 Participants
Age, Continuous	44.39 years STANDARD_DEVIATION 11.57 • n=165 Participants	43.17 years STANDARD_DEVIATION 11.78 • n=165 Participants	43.78 years STANDARD_DEVIATION 11.68 • n=330 Participants
Sex: Female, Male Female	57 Participants n=165 Participants • Missing one data point from Control	46 Participants n=164 Participants • Missing one data point from Control	103 Participants n=329 Participants • Missing one data point from Control
Sex: Female, Male Male	108 Participants n=165 Participants • Missing one data point from Control	118 Participants n=164 Participants • Missing one data point from Control	226 Participants n=329 Participants • Missing one data point from Control
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=165 Participants	1 Participants n=165 Participants	2 Participants n=330 Participants
Race (NIH/OMB) Asian	2 Participants n=165 Participants	3 Participants n=165 Participants	5 Participants n=330 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=165 Participants	0 Participants n=165 Participants	0 Participants n=330 Participants
Race (NIH/OMB) Black or African American	76 Participants n=165 Participants	86 Participants n=165 Participants	162 Participants n=330 Participants
Race (NIH/OMB) White	78 Participants n=165 Participants	68 Participants n=165 Participants	146 Participants n=330 Participants
Race (NIH/OMB) More than one race	0 Participants n=165 Participants	0 Participants n=165 Participants	0 Participants n=330 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=165 Participants	7 Participants n=165 Participants	15 Participants n=330 Participants
Region of Enrollment United States	165 Participants n=165 Participants	165 Participants n=165 Participants	330 Participants n=330 Participants
Marital Status Married	106 Participants n=165 Participants • One data point missing from Marital status	104 Participants n=164 Participants • One data point missing from Marital status	210 Participants n=329 Participants • One data point missing from Marital status
Marital Status Separated	6 Participants n=165 Participants • One data point missing from Marital status	3 Participants n=164 Participants • One data point missing from Marital status	9 Participants n=329 Participants • One data point missing from Marital status
Marital Status Divorced	29 Participants n=165 Participants • One data point missing from Marital status	29 Participants n=164 Participants • One data point missing from Marital status	58 Participants n=329 Participants • One data point missing from Marital status
Marital Status Never Married	16 Participants n=165 Participants • One data point missing from Marital status	22 Participants n=164 Participants • One data point missing from Marital status	38 Participants n=329 Participants • One data point missing from Marital status
Marital Status Widowed	2 Participants n=165 Participants • One data point missing from Marital status	1 Participants n=164 Participants • One data point missing from Marital status	3 Participants n=329 Participants • One data point missing from Marital status
Marital Status Other	6 Participants n=165 Participants • One data point missing from Marital status	5 Participants n=164 Participants • One data point missing from Marital status	11 Participants n=329 Participants • One data point missing from Marital status
Employment Status Full Time	79 Participants n=165 Participants • 2 data points missing from Baseline assessment	85 Participants n=163 Participants • 2 data points missing from Baseline assessment	164 Participants n=328 Participants • 2 data points missing from Baseline assessment
Employment Status Retired	22 Participants n=165 Participants • 2 data points missing from Baseline assessment	18 Participants n=163 Participants • 2 data points missing from Baseline assessment	40 Participants n=328 Participants • 2 data points missing from Baseline assessment
Employment Status Part Time	25 Participants n=165 Participants • 2 data points missing from Baseline assessment	17 Participants n=163 Participants • 2 data points missing from Baseline assessment	42 Participants n=328 Participants • 2 data points missing from Baseline assessment
Employment Status Student	15 Participants n=165 Participants • 2 data points missing from Baseline assessment	15 Participants n=163 Participants • 2 data points missing from Baseline assessment	30 Participants n=328 Participants • 2 data points missing from Baseline assessment
Employment Status Unemployed	24 Participants n=165 Participants • 2 data points missing from Baseline assessment	28 Participants n=163 Participants • 2 data points missing from Baseline assessment	52 Participants n=328 Participants • 2 data points missing from Baseline assessment
Combat Veteran status No Combat	48 Participants n=165 Participants • 3 data points missing for Combat Era	52 Participants n=162 Participants • 3 data points missing for Combat Era	100 Participants n=327 Participants • 3 data points missing for Combat Era
Combat Veteran status WWII/Korea	1 Participants n=165 Participants • 3 data points missing for Combat Era	1 Participants n=162 Participants • 3 data points missing for Combat Era	2 Participants n=327 Participants • 3 data points missing for Combat Era
Combat Veteran status Vietnam	5 Participants n=165 Participants • 3 data points missing for Combat Era	2 Participants n=162 Participants • 3 data points missing for Combat Era	7 Participants n=327 Participants • 3 data points missing for Combat Era
Combat Veteran status Desert Storm	17 Participants n=165 Participants • 3 data points missing for Combat Era	10 Participants n=162 Participants • 3 data points missing for Combat Era	27 Participants n=327 Participants • 3 data points missing for Combat Era
Combat Veteran status OEF/OIF	92 Participants n=165 Participants • 3 data points missing for Combat Era	93 Participants n=162 Participants • 3 data points missing for Combat Era	185 Participants n=327 Participants • 3 data points missing for Combat Era
Combat Veteran status Other	2 Participants n=165 Participants • 3 data points missing for Combat Era	4 Participants n=162 Participants • 3 data points missing for Combat Era	6 Participants n=327 Participants • 3 data points missing for Combat Era