Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03581981
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2018-06-27
Brief Title:
Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Function Through Primary Care Treatment of PTSD
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PE-PC
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 40 to 62 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 862 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 VHADepartment 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 andor 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 inclusionexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None