NCT03485391: PEP

Peer Social Support During In Vivo Exposure for PTSD

Completed NA Results posted Last updated 16 August 2024

What this trial tests

NA trial testing Prolonged Exposure in Stress Disorders, Post-Traumatic in 109 participants. Completed in 31 May 2023.

Timeline

1 May 2018

Primary endpoint
3 March 2023

31 May 2023

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	109
Start date	1 May 2018
Primary completion	3 March 2023
Estimated completion	31 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Prolonged Exposure

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →
• Anxiety Disorders — all drugs for Anxiety Disorders →
• Mental Disorder — all drugs for Mental Disorder →
• Traumatic Disorder — all drugs for Traumatic Disorder →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Stress Disorders, Post-Traumatic or Anxiety Disorders. 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.

Clinical Administrated PTSD Scale (CAPS) Primary · 36 weeks

The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion

Group	Value	95% CI
PE+Exposure Workout Buddy	25.44	± 11.966
PE+Peer General Support	24.44	± 11.389

PTSD Checklist, 5th Version (PCL-5) Secondary · 13 weeks

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.

Group	Value	95% CI
PE+Exposure Workout Buddy	32.1335	± 18.77834
PE+Peer General Support	34.8677	± 18.55918

PTSD Checklist, 5th Version (PCL-5) Secondary · 24 weeks

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.

Group	Value	95% CI
PE+Exposure Workout Buddy	36.7449	± 16.73793
PE+Peer General Support	34.8181	± 16.53160

PTSD Checklist, 5th Version (PCL-5) Secondary · 36 weeks

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items (ranging from 0-4 per item). Higher scores indicate worse outcomes.

Group	Value	95% CI
PE+Exposure Workout Buddy	40.2105	± 15.47735
PE+Peer General Support	37.1678	± 17.18023

Patient Health Questionnaire (PHQ-9) Secondary · 13 weeks

The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Highe

Group	Value	95% CI
PE+Exposure Workout Buddy	11.2105	± 6.07833
PE+Peer General Support	11.5292	± 5.83646

Patient Health Questionnaire (PHQ-9) Secondary · 24 weeks

The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Highe

Group	Value	95% CI
PE+Exposure Workout Buddy	12.0063	± 5.36715
PE+Peer General Support	11.1333	± 5.98522

Patient Health Questionnaire (PHQ-9) Secondary · 36 weeks

The Patient Health Questionnaire -9 is widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with other depression measures. Its 9 items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. A total severity score (range - 0-27) can be obtained by summing the scores for each of the 9 items (ranging from 0-3 per item). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Highe

Group	Value	95% CI
PE+Exposure Workout Buddy	12.5554	± 5.17738
PE+Peer General Support	12.2859	± 6.03785

Combat Exposure Scale (CES) Secondary · Baseline

The Combat Exposure Scale (CES) is a 7-item self-report measure that assesses wartime stressors experienced by combatants. Items are rated on a 5-point frequency (1 = "no" or "never" to 5 = "more than 50 times"), 5-point duration (1 = "never" to 5 = "more than 6 months"), 4-point frequency (1 = "no" to 4 = "more than 12 times") or 4-point degree of loss (1 = "no one" to 4 = "more than 50%") scale. Scores for each item are converted and then summed to obtain a total score. Total scores (of the converted items) range from 0 to 41, with lower scores indicating 'light' exposure and higher scores i

Group	Value	95% CI
PE+Exposure Workout Buddy	4.1132	± 5.97965
PE+Peer General Support	5.2400	± 6.60723

Sponsor's own description

Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included. There will be no randomization; all participants will receive the peer support 'workout buddy' for exposure therapy assignments.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial.
   Hernandez-Tejada MA, Muzzy W, Price M, Hamski S, et al · · 2020 · cited 5× · PMID 32345329 · DOI 10.1186/s13063-020-04302-5
2. Peer Support During In Vivo Exposure Homework to Reverse Attrition from Prolonged Exposure Therapy for PTSD: Description of a Randomized Controlled Trial
   Hernandez-Tejada M, Muzzy W, Price M, Hamski S, et al · · 2020 · DOI 10.21203/rs.3.rs-18549/v1