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Improving Function Through Primary Care Treatment of PTSD (PE-PC)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure for Primary Care (PE-PC)
Treatment as Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Any era Veterans seeking care in VA PC for PTSD symptoms (PCL-5 28) and PTSD confirmed based on CAPS
  • English speaking
  • Report significant impairment in function related to PTSD symptoms as noted on intake WHODAS
  • Report that they want treatment for PTSD
  • If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment

Exclusion Criteria:

  • Other primary clinical issue that would interfere with PTSD treatment
  • Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS (46)) that requires:

    • PTSD + interested and consent to study
  • PCP Screen:

    • PC-PTSD + Intake
  • PCMHI Provider:

    • [PCL 28] + brief interview

      • No PTSD OR
      • Not interested in treatment OR
      • Not interested in study
  • Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen
  • Psychosis or unmanaged bipolar disorder
  • Moderate to severe substance use disorder in the past 8 weeks
  • Patients who are currently receiving talk therapy for trauma-related symptoms

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Ralph H. Johnson VA Medical Center, Charleston, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged Exposure for Primary Care (PE-PC)

Treatment as Usual (TAU)

Arm Description

Brief version of PE provided in 30 minute sessions in PC

Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.

Outcomes

Primary Outcome Measures

World Health Organization Disability Assessment Scale Change
Change in total score between time points
World Health Organization Disability Assessment Scale
total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population
World Health Organization Disability Assessment Scale
total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population

Secondary Outcome Measures

Clinician Administered PTSD Scale for DSM 5 (CAPS5) Change
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
PTSD Checklist for DSM5 (PCL-5) Change
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Patient Health Questionnaire- 9 (PHQ-9) Change
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Clinician Administered PTSD Scale for DSM 5 (CAPS5)
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Clinician Administered PTSD Scale for DSM 5 (CAPS5
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
PTSD Checklist for DSM5 (PCL-5)
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
PTSD Checklist for DSM5 (PCL-5)
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Patient Health Questionnaire- 9 (PHQ-9)
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Patient Health Questionnaire- 9 (PHQ-9)
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+

Full Information

First Posted
June 27, 2018
Last Updated
February 1, 2023
Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center, VA Ann Arbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03581981
Brief Title
Improving Function Through Primary Care Treatment of PTSD
Acronym
PE-PC
Official Title
Improving Function Through Primary Care Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center, VA Ann Arbor Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed project will examine a promising brief therapy for PTSD for use in VHA Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services.
Detailed Description
Posttraumatic stress disorder (PTSD) is a debilitating and costly mental health issue (Greenberg, Sisitsky et al. 1999, Hoge, Terhakopian et al. 2007). RAND reported an estimated two-year cost of $4.0 to $6.2 billion US dollars for mental health issues from the current conflicts in Iraq and Afghanistan and further estimated that providing evidence-based treatments for PTSD and depression could save an estimated $86.2 million (Tanielian, et al. 2008). Even modest reductions in PTSD severity have been related to increased probability of positive function outcomes (Smith, et al. 2005). Prolonged Exposure (PE) therapy (Foa, et al. 2000, Foa, et al. 2005, Schnurr, et al. 2007) is an effective, first-line treatment for PTSD (IOM 2007, VA/DOD 2010). While highly effective, PE is provided in specialty mental health settings typically in 8 to 15, weekly 90 minute individual sessions. Veterans with PTSD are often reluctant to seek care in specialty mental health, and, as a result, many are treated solely in primary care and do not have access to this effective intervention (Possemato, et al. 2011). While the DoD and VA have actively integrated behavioral health providers into their primary care clinics (Maguen, et al. 2010, Seal, et al. 2011), current behavioral interventions for PTSD in primary care are often inconsistent with clinical practice guidelines and/or not effective (Possemato, et al. 2011). Since functional outcomes are critical, the investigators intend to extend beyond assessing the impact of PE-PC on clinical outcomes to function. Thus, there is a clear and urgent need to further develop, validate, and disseminate evidence-based psychotherapeutic treatments for PTSD in integrated VHA PC-MHI with a focus on functional outcomes. To fill this need and gap in care the study investigators developed a Brief Prolonged Exposure for Primary Care (PE-PC) treatment protocol with 4, 30-minute sessions for use in a stepped care model. A pilot study in military treatment facilities found PE-PC resulted in reductions in PTSD that were maintained at 6- and 12-month follow-up (Cigrang, et al, 2015). Preliminary results from a randomized controlled trial (RCT; PI: Cigrang; CoI: Rauch) of PE-PC compared to minimal attention control (MAC, including continuation of any PC initiated treatment) found a significantly larger reduction in PTSD severity (measured by PCL) in PE-PC than MAC (between group d = .78, p = .01). The strength of these initial findings is limited by lack of functional outcomes and examination of impact in VHA. While Service Members and Veterans have many similarities, potential differences in motivation for treatment and other factors may influence the efficacy of the protocol especially when examining changes in function. The proposed study will randomize 120 Veterans at Ralph H. Johnson VAMC presenting in primary care with PTSD who meet minimal inclusion/exclusion criteria to 6 weeks of PE-PC or PC-MHI-treatment as usual (TAU). Recruitment will occur over 36 months. All Veterans will complete a baseline assessment prior to randomization and post-treatment follow-up assessments at Weeks 6, 12, and 24 post-randomization. Primary outcome will be function assessed as self-reported role function in several domains. In addition, the investigators will examine symptoms severity and effectiveness, acceptability, and utilization associated with PE-PC or PCMHI-TAU in the 6 months prior to randomization and 6 months following treatment completion. PE-PC may allow access to effective treatment and efficient allocation of PTSD specialty treatment resources in the VHA. This topic is of key relevance to Veteran mental health care and can provide a new access point for high quality PTSD care to improve function allowing many more Veterans to experience improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessors will not be aware of patient condition and patients will be instructed and reminded not to disclose information that may lead to unblinding
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure for Primary Care (PE-PC)
Arm Type
Experimental
Arm Description
Brief version of PE provided in 30 minute sessions in PC
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure for Primary Care (PE-PC)
Other Intervention Name(s)
PE-PC
Intervention Description
Brief version of PE provided in 30 minute sessions in PC
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Primary Outcome Measure Information:
Title
World Health Organization Disability Assessment Scale Change
Description
Change in total score between time points
Time Frame
Week 0 to Week 6
Title
World Health Organization Disability Assessment Scale
Description
total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population
Time Frame
Week 12
Title
World Health Organization Disability Assessment Scale
Description
total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale for DSM 5 (CAPS5) Change
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 0, 6, 12, 24
Title
PTSD Checklist for DSM5 (PCL-5) Change
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 0, 6, 12, 24
Title
Patient Health Questionnaire- 9 (PHQ-9) Change
Description
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Time Frame
Week 0, 6, 12, 24
Title
Clinician Administered PTSD Scale for DSM 5 (CAPS5)
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 12
Title
Clinician Administered PTSD Scale for DSM 5 (CAPS5
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 24
Title
PTSD Checklist for DSM5 (PCL-5)
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 12
Title
PTSD Checklist for DSM5 (PCL-5)
Description
Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established
Time Frame
Week 24
Title
Patient Health Questionnaire- 9 (PHQ-9)
Description
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Time Frame
Week 12
Title
Patient Health Questionnaire- 9 (PHQ-9)
Description
Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any era Veterans seeking care in VA PC for PTSD symptoms (PCL-5 28) and PTSD confirmed based on CAPS English speaking Report significant impairment in function related to PTSD symptoms as noted on intake WHODAS Report that they want treatment for PTSD If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment Exclusion Criteria: Other primary clinical issue that would interfere with PTSD treatment Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS (46)) that requires: PTSD + interested and consent to study PCP Screen: PC-PTSD + Intake PCMHI Provider: [PCL 28] + brief interview No PTSD OR Not interested in treatment OR Not interested in study Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen Psychosis or unmanaged bipolar disorder Moderate to severe substance use disorder in the past 8 weeks Patients who are currently receiving talk therapy for trauma-related symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila A.M. Rauch, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35964868
Citation
Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K, Cigrang J. Improving function through primary care treatment of PTSD: The IMPACT study protocol. Contemp Clin Trials. 2022 Sep;120:106881. doi: 10.1016/j.cct.2022.106881. Epub 2022 Aug 12.
Results Reference
background
PubMed Identifier
34291832
Citation
McLean CP, Back SE, Capone C, Morland L, Norman SB, Rauch SAM, Schnurr PP, Teng E, Acierno R. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research. J Trauma Stress. 2022 Feb;35(1):308-313. doi: 10.1002/jts.22718. Epub 2021 Jul 22.
Results Reference
background

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Improving Function Through Primary Care Treatment of PTSD

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