Clinical trial NCT02313818: Variable-length Cognitive Processing Therapy for Combat-Related PTSD
Official title: Variable-length Cognitive Processing Therapy for Combat-Related PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Cognitive Processing Therapy
Active Duty Military
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boston VA Research Institute, Inc.
name: The University of Texas Health Science Center at San Antonio
name: STRONG STAR Consortium
First posted: 2014-12-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Variable length Cognitive Processing Therapy
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.

Detailed description: The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Adult male and female combat veterans who deployed in support of combat operations following 9/11
* Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
* Speak and read English

Exclusion Criteria:

* Current suicide or homicide risk meriting crisis intervention.
* Active psychosis.
* Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
* Local availability of fewer than 5 months
* Late-phase Med Board status, awaiting percentages
* Undergoing a chapter

Primary outcomes:
measure: Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)
timeFrame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
measure: Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Secondary outcomes:
measure: Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9
timeFrame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R Darnall Army Medical Center
state: Texas
Study officials:
affiliation: Duke University
name: Patricia A Resick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foa EB, Zandberg LJ, McLean CP, Rosenfield D, Fitzgerald H, Tuerk PW, Wangelin BC, Young-McCaughan S, Peterson AL. The efficacy of 90-minute versus 60-minute sessions of prolonged exposure for posttraumatic stress disorder: Design of a randomized controlled trial in active duty military personnel. Psychol Trauma. 2019 Mar;11(3):307-313. doi: 10.1037/tra0000351. Epub 2018 Feb 12.