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

Improving Function Through Primary Care Treatment of PTSD

The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure for Primary Care (PE-PC); Behavioral: Treatment as Usual

Detailed Description

Posttraumatic stress disorder (PTSD) is a debilitating and costly mental health issue (Greenberg, Sisitsky et al. 1999, Hoge, Terhakopian et al. 2007). PTSD has 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, VHA/Department of Defense (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 Veterans Administration (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 Primary Care Mental Health Integration (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; Co-Investigator: 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 Veterans Administration Medical Center (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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033-4004
      • Atlanta VA Medical and Rehab Center, Decatur, GA
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Any era Veterans seeking care in VA PC for PTSD symptoms [PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
• English speaking
• Report significant impairment in function related to PTSD symptoms as noted on intake World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
• 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) that requires:

  • PTSD + interested and consent to study

• Primary Care Provider (PCP) Screen:

  • Primary Care- Posttraumatic Stress Disorder 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure for Primary Care (PE-PC); Brief version of PE provided in 30 minute sessions in PC	Behavioral: Prolonged Exposure for Primary Care (PE-PC); Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC); Other Names: PE-PC
Active Comparator: Treatment as Usual (TAU); Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)- Treatment as Usual (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 Mental Health (MH)), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.	Behavioral: Treatment as Usual; Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)-Treatment as Usual (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.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Disability Assessment Scale 2.0 Change	Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established.	Week 6 to Week 0
World Health Organization Disability Assessment Scale 2.0	WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.	Week 12
World Health Organization Disability Assessment Scale 2.0	WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change	Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.	Week 6 to Week 0
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change	Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.	Week 6 to Week 0
Patient Health Questionnaire- 9 (PHQ-9) Change	Change scores range between Week 6 and Week 0 time points from 27 (Most severe depression after no depression) to 0 (no change) to -27 (No depression after most severe depression). Lower change score indicates more reduction in depression. Cut points for this change measure have not yet been established.	Week 6 to week 0
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)	CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.	Week 12
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)	CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.	Week 24
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)	PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.	Week 12
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)	PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.	Week 24
Patient Health Questionnaire- 9 (PHQ-9)	PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+	Week 12
Patient Health Questionnaire- 9 (PHQ-9)	PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+	Week 24

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: VA Ann Arbor Healthcare System; Ralph H. Johnson VA Medical Center
• Investigators: Principal Investigator: Sheila A Rauch, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 12, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: posttraumatic stress disorder
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: D2625-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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