Clinical trial NCT03581981: Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)
Official title: Improving Function Through Primary Care Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Ralph H. Johnson VA Medical Center
name: VA Ann Arbor Healthcare System
First posted: 2018-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: World Health Organization Disability Assessment Scale 2.0 Change
timeFrame: Week 6 to Week 0
measure: World Health Organization Disability Assessment Scale 2.0
timeFrame: Week 12
measure: World Health Organization Disability Assessment Scale 2.0
timeFrame: Week 24
Secondary outcomes:
measure: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change
timeFrame: Week 6 to Week 0
measure: PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change
timeFrame: Week 6 to Week 0
measure: Patient Health Questionnaire- 9 (PHQ-9) Change
timeFrame: Week 6 to week 0
measure: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
timeFrame: Week 12
measure: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
timeFrame: Week 24
measure: PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
timeFrame: Week 12
measure: PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
timeFrame: Week 24
measure: Patient Health Questionnaire- 9 (PHQ-9)
timeFrame: Week 12
measure: Patient Health Questionnaire- 9 (PHQ-9)
timeFrame: Week 24
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Sheila A Rauch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.