Comparative Effectiveness Research in Veterans With PTSD

NACompletedINTERVENTIONAL
Enrollment

916

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

March 18, 2019

Study Completion Date

April 18, 2019

Conditions
Post-Traumatic Stress Disorder
Interventions
BEHAVIORAL

Cognitive Processing Therapy (CPT)

CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.

BEHAVIORAL

Prolonged Exposure (PE)

"PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."

Trial Locations (18)

27705

Durham VA Medical Center, Durham, NC, Durham

30033

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

35404

Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa

44106

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

45220

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

53705

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

55417

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

70112

Southeast Louisiana Veterans Health Care System, New Orleans, LA, New Orleans

77030

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

84148

VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City

85012

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

90822

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

94121

San Francisco VA Medical Center, San Francisco, CA, San Francisco

98108

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

94304-1290

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

60141-5000

Edward Hines Jr. VA Hospital, Hines, IL, Hines

87108-5153

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque

05009-0001

White River Junction VA Medical Center, White River Junction, VT, White River Junction

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT01928732 - Comparative Effectiveness Research in Veterans With PTSD | Biotech Hunter | Biotech Hunter