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Peer Social Support During In Vivo Exposure for PTSD (PEP)

Primary Purpose

Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participant Inclusion Criteria:

  1. Adult male or female over the age of 18 that has served, or is currently serving in the military.
  2. Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25, and a PCL-5 score of ≥25.
  3. Attempted PE treatment in the past, but did not complete treatment (defined as dropping out from treatment or refusal to engage in in vivo exposure assignments) OR identified as "at-risk" of dropping out of current exposure therapy treatment (defined as failure to complete 3 sessions of therapy within any 6 week period or verbally indicating that they are not comfortable with the exposure activities).

Participant Exclusion Criteria:

  1. Active psychosis or dementia at screening.
  2. Suicidal ideation with clear intent.
  3. Concurrent enrollment in another clinical trial for PTSD or depression.

Peer Inclusion Criteria:

  1. Adult male or female over the age of 18 that has served, or is currently serving, in the military.
  2. Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program.
  3. PCL-5 score of 32 or lower.

Peer Exclusion Criteria:

  1. Active psychosis or dementia at screening.
  2. Suicidal ideation with clear intent.

Sites / Locations

  • Ralph H. Johnson VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PE+Exposure Workout Buddy

PE+Peer General Support

Arm Description

Prolonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure.

Prolonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress.

Outcomes

Primary Outcome Measures

Clinical Administrated PTSD Scale (CAPS)
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 E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80.

Secondary Outcome Measures

Mini International Neuropsychiatric Interview (M.I.N.I.)
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Mini International Neuropsychiatric Interview (M.I.N.I.)
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
PTSD Checklist, 5th Version (PCL-5)
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. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
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. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
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. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
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. Description information provided by the National Center for PTSD.
Deployment Risk and Resilience Inventory-2 (DRRI-2)
The Deployment Risk and Resilience Inventory-2 (DRRI-2) is a suite of 17 individual scales that assess key deployment-related risk and resilience factors with demonstrated implications for Veterans' post-deployment health.
Patient Health Questionnaire (PHQ-9)
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.
Patient Health Questionnaire (PHQ-9)
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.
Patient Health Questionnaire (PHQ-9)
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.
Patient Health Questionnaire (PHQ-9)
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.
Medical Outcome Study Short Form-36 Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Medical Outcome Study Short Form-36 Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Medical Outcome Study Short Form-36 Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Medical Outcome Study Short Form-36 Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Combat Exposure Scale (CES)
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 range from 0-41 and is calculated by using a sum of weighted scores, which can be classified into one of five categories of combat exposure ranging from "light" to "heavy."
Treatment Credibility Questionnaire
This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales. The questionnaire asks how the participant feels about the current treatment she is receiving, how logical it seems, how likely she would be to recommend it to a friend, and how successful she believes it is in decreasing different symptoms of PTSD, such as fear.
Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
The Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA) is 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. There are 16 questions which can be rated from "N/A" to "Excellent." There is no total score for this measure.
PEP Satisfaction Scale (PEP-SS)
The PEP Satisfaction Scale (PEP-SS) is a 25-item measure that assesses participant satisfaction with the peer support. Items range from "poor" to "excellent" with some questions having a "n/a" option. Lower scores indicate worse outcomes. There is no total score for this measure.
Barriers to Therapeutic Exposure Scale (BTES)
The Barriers to Therapeutic Exposure Scale (BTES) is a 45 item questionnaire assessing factors that may affect participation in Prolonged Exposure therapy. Items range from "never a problem" to "very often a problem" with lower scores indicating worse outcomes. There is no total score for this measure.

Full Information

First Posted
March 7, 2018
Last Updated
August 25, 2023
Sponsor
Medical University of South Carolina
Collaborators
Charleston Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03485391
Brief Title
Peer Social Support During In Vivo Exposure for PTSD
Acronym
PEP
Official Title
Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Charleston Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center catchment area. Participants will have been assigned to exposure therapy for PTSD and either started treatment, or dropped out before treatment; peers will have successfully completed exposure therapy for PTSD. Those eligible to participate will also include Veterans who are identified as "at-risk" of dropping out, Veterans who are uncomfortable completing in vivo exposure activities, and those who may have PTSD symptoms, but at the sub-threshold level. Participants will receive 8-12 weekly sessions of exposure therapy treatment with assistance of a PE Peer. Half of subjects will be randomized to the PE+Workout Buddy condition, where they will complete treatment with the assistance of a Veteran who will meet them at least once per week for in vivo exposure therapy assignments, for 3-4 weeks at the beginning of treatment. Half of subjects will be randomized to the PE+General Support condition, where they will complete treatment with the assistance of a Veteran who will call them via telephone once per week to encourage session attendance and ask about treatment progress, life stresses, etc. General support peers will also meeting Veterans 2-4 times per month to check in about treatment progress. All participants and peers will be consented. Participants will be assessed at baseline, post-treatment, and 3- & 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder, Traumatic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PE+Exposure Workout Buddy
Arm Type
Experimental
Arm Description
Prolonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure.
Arm Title
PE+Peer General Support
Arm Type
Active Comparator
Arm Description
Prolonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Description
Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.
Primary Outcome Measure Information:
Title
Clinical Administrated PTSD Scale (CAPS)
Description
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 E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview (M.I.N.I.)
Description
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Time Frame
Baseline
Title
Mini International Neuropsychiatric Interview (M.I.N.I.)
Description
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Time Frame
36 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
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. Description information provided by the National Center for PTSD.
Time Frame
Baseline
Title
PTSD Checklist, 5th Version (PCL-5)
Description
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. Description information provided by the National Center for PTSD.
Time Frame
13 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
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. Description information provided by the National Center for PTSD.
Time Frame
24 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
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. Description information provided by the National Center for PTSD.
Time Frame
36 weeks
Title
Deployment Risk and Resilience Inventory-2 (DRRI-2)
Description
The Deployment Risk and Resilience Inventory-2 (DRRI-2) is a suite of 17 individual scales that assess key deployment-related risk and resilience factors with demonstrated implications for Veterans' post-deployment health.
Time Frame
Baseline
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
13 weeks
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
24 weeks
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
36 weeks
Title
Medical Outcome Study Short Form-36 Health Survey (SF-36)
Description
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Time Frame
Baseline
Title
Medical Outcome Study Short Form-36 Health Survey (SF-36)
Description
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Time Frame
13 weeks
Title
Medical Outcome Study Short Form-36 Health Survey (SF-36)
Description
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Time Frame
24 weeks
Title
Medical Outcome Study Short Form-36 Health Survey (SF-36)
Description
The SF-36 is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. The SF-36 has good test-retest reliability as well as sensitivity to change in health.
Time Frame
36 weeks
Title
Combat Exposure Scale (CES)
Description
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 range from 0-41 and is calculated by using a sum of weighted scores, which can be classified into one of five categories of combat exposure ranging from "light" to "heavy."
Time Frame
Baseline
Title
Treatment Credibility Questionnaire
Description
This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales. The questionnaire asks how the participant feels about the current treatment she is receiving, how logical it seems, how likely she would be to recommend it to a friend, and how successful she believes it is in decreasing different symptoms of PTSD, such as fear.
Time Frame
2 weeks
Title
Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Description
The Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA) is 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. There are 16 questions which can be rated from "N/A" to "Excellent." There is no total score for this measure.
Time Frame
13 weeks
Title
PEP Satisfaction Scale (PEP-SS)
Description
The PEP Satisfaction Scale (PEP-SS) is a 25-item measure that assesses participant satisfaction with the peer support. Items range from "poor" to "excellent" with some questions having a "n/a" option. Lower scores indicate worse outcomes. There is no total score for this measure.
Time Frame
13 weeks
Title
Barriers to Therapeutic Exposure Scale (BTES)
Description
The Barriers to Therapeutic Exposure Scale (BTES) is a 45 item questionnaire assessing factors that may affect participation in Prolonged Exposure therapy. Items range from "never a problem" to "very often a problem" with lower scores indicating worse outcomes. There is no total score for this measure.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participant Inclusion Criteria: Adult male or female over the age of 18 that has served, or is currently serving in the military. Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25, and a PCL-5 score of ≥25. Attempted PE treatment in the past, but did not complete treatment (defined as dropping out from treatment or refusal to engage in in vivo exposure assignments) OR identified as "at-risk" of dropping out of current exposure therapy treatment (defined as failure to complete 3 sessions of therapy within any 6 week period or verbally indicating that they are not comfortable with the exposure activities). Participant Exclusion Criteria: Active psychosis or dementia at screening. Suicidal ideation with clear intent. Concurrent enrollment in another clinical trial for PTSD or depression. Peer Inclusion Criteria: Adult male or female over the age of 18 that has served, or is currently serving, in the military. Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program. PCL-5 score of 32 or lower. Peer Exclusion Criteria: Active psychosis or dementia at screening. Suicidal ideation with clear intent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Muzzy, MRA, MLIS
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Acierno, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32345329
Citation
Hernandez-Tejada MA, Muzzy W, Price M, Hamski S, Hart S, Foa E, Acierno R. 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. Trials. 2020 Apr 28;21(1):366. doi: 10.1186/s13063-020-04302-5.
Results Reference
derived

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Peer Social Support During In Vivo Exposure for PTSD

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