Improving Function Through Primary Care Treatment of PTSD
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | April 1, 2019 |
| End Date: | September 30, 2022 |
| Contact: | Sheila A Rauch, PhD |
| Email: | Sheila.Rauch@va.gov |
| Phone: | (404) 621-3122 |
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.
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.
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.
(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.
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
We found this trial at
1
site
Decatur, Georgia 30033
Principal Investigator: Sheila A.M. Rauch, PhD
Phone: (404) 321-6111
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