Trial Outcomes & Findings for Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans (NCT NCT02486692)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

pre-treatment (baseline) & post-treatment (two-week) assessment

Results posted on

2019-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Phase II-Experimental Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition Education and Print materials only
Overall Study STARTED	30	30
Overall Study COMPLETED	26	23
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II-Experimental Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition Education and Print materials only
Overall Study did not login for randomization	4	7

Baseline Characteristics

Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II-Experimental n=30 Participants Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition n=30 Participants Education and Print materials only	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	42.27 years n=5 Participants	42.13 years n=7 Participants	42.20 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-treatment (baseline) & post-treatment (two-week) assessment

Population: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access website portal to obtain their randomization assignment. The EASI was also missing for 1 participant at post.

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.

Outcome measures

Outcome measures
Measure	Phase II-Experimental n=26 Participants Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition n=22 Participants Education and Print materials only
Endorsed and Anticipated Stigma Inventory (EASI) pre-treatment (baseline) mean	57.9 units on a scale Standard Deviation 27.2	62.3 units on a scale Standard Deviation 31.4
Endorsed and Anticipated Stigma Inventory (EASI) post-treatment (2-week) mean	57.5 units on a scale Standard Deviation 33.1	54.1 units on a scale Standard Deviation 30.7

PRIMARY outcome

Timeframe: pre-treatment (baseline) & post-treatment (2-week) assessment

Population: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment.

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.

Outcome measures

Outcome measures
Measure	Phase II-Experimental n=26 Participants Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition n=23 Participants Education and Print materials only
PTSD Checklist (PCL-V) pre-treatment (baseline) mean (sd)	51.1 units on a scale Standard Deviation 10.6	52.1 units on a scale Standard Deviation 11.4
PTSD Checklist (PCL-V) post-treatment (2-week) mean (sd)	49.4 units on a scale Standard Deviation 9.7	49.5 units on a scale Standard Deviation 12.5

PRIMARY outcome

Timeframe: two weeks post assessment

Population: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment. Data was also missing for 1 participant at post.

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.

Outcome measures

Outcome measures
Measure	Phase II-Experimental n=26 Participants Participants using AboutFace AboutFace Website: AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and treatment for PTSD.	Phase II- Usual Care Condition n=22 Participants Education and Print materials only
PTSD Treatment Initiators	20 Participants	15 Participants

Adverse Events

Phase II- Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase II- Usual Care Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anouk Grubaugh

Ralph H. Johnson VAMC

Phone: 843-532-6672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place