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

• ClinicalTrials.gov Identifier: NCT03485391
• Recruitment Status: Recruiting
• First Posted: April 2, 2018
• Last Update Posted: August 20, 2021
• Sponsor: Medical University of South Carolina
• Collaborator: Charleston Research Institute
• Information provided by (Responsible Party): Medical University of South Carolina

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.

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic; Anxiety Disorders; Mental Disorder; Traumatic Disorder	Behavioral: Prolonged Exposure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: PE+Exposure Workout Buddy; 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.	Behavioral: Prolonged Exposure; 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.
Active Comparator: PE+Peer General Support; 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.	Behavioral: Prolonged Exposure; 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.

Outcome Measures

Primary Outcome Measures :

1. Clinical Administrated PTSD Scale (CAPS) [ Time Frame: 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 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 :

1. Mini International Neuropsychiatric Interview (M.I.N.I.) [ Time Frame: Baseline ]
   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.
2. Mini International Neuropsychiatric Interview (M.I.N.I.) [ Time Frame: 36 weeks ]
   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.
3. PTSD Checklist, 5th Version (PCL-5) [ Time Frame: Baseline ]
   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.
4. PTSD Checklist, 5th Version (PCL-5) [ Time Frame: 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. Description information provided by the National Center for PTSD.
5. PTSD Checklist, 5th Version (PCL-5) [ Time Frame: 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. Description information provided by the National Center for PTSD.
6. PTSD Checklist, 5th Version (PCL-5) [ Time Frame: 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. Description information provided by the National Center for PTSD.
7. Deployment Risk and Resilience Inventory-2 (DRRI-2) [ Time Frame: Baseline ]
   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.
8. Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline ]
   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.
9. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.
10. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.
11. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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.
12. Medical Outcome Study Short Form-36 Health Survey (SF-36) [ Time Frame: Baseline ]
    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.
13. Medical Outcome Study Short Form-36 Health Survey (SF-36) [ Time Frame: 13 weeks ]
    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.
14. Medical Outcome Study Short Form-36 Health Survey (SF-36) [ Time Frame: 24 weeks ]
    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.
15. Medical Outcome Study Short Form-36 Health Survey (SF-36) [ Time Frame: 36 weeks ]
    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.
16. Combat Exposure Scale (CES) [ Time Frame: 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 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."
17. Treatment Credibility Questionnaire [ Time Frame: 2 weeks ]
    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.
18. Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA) [ Time Frame: 13 weeks ]
    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.
19. PEP Satisfaction Scale (PEP-SS) [ Time Frame: 13 weeks ]
    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.
20. Barriers to Therapeutic Exposure Scale (BTES) [ Time Frame: 13 weeks ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Wendy Muzzy, MRA,MLIS; 843-792-8068; muzzy@musc.edu

Contact: Stephanie Hart, MPH; 843-789-6519; zeigls@musc.edu

Locations

United States, South Carolina

Ralph H. Johnson VA Medical Center; Recruiting

Charleston, South Carolina, United States, 29401

Contact: Stephanie M Hart, MPH 843-789-6519 zeigls@musc.edu

Contact: Stephanie Hamski, MA 843-577-5011 ext 5110 lynnst@musc.edu

Sponsors and Collaborators

Medical University of South Carolina

Charleston Research Institute

Investigators

• Principal Investigator: Wendy Muzzy, MRA,MLIS; Medical University of South Carolina
• Principal Investigator: Ron Acierno, PhD; Ralph H. Johnson VA Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03485391
• Other Study ID Numbers: MUSC Pro00075914
• First Posted: April 2, 2018
• Last Update Posted: August 20, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Mental Disorders; Stress Disorders, Post-Traumatic; Pathologic Processes; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders