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Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Not Applicable
Completed
Conditions
Posttraumatic Stress Disorder
Interventions
Behavioral: Cognitive Processing Therapy-Cognitive Only
Registration Number
NCT02313818
Lead Sponsor
Duke University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
130
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
CPT-CCognitive Processing Therapy-Cognitive OnlyCognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.
Primary Outcome Measures
NameTimeMethod
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.

Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5

Secondary Outcome Measures
NameTimeMethod
Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms (Kroenke, Spitzer, \& Williams, 2001). It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for DSM MDD. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score.

Trial Locations

Locations (1)

Carl R Darnall Army Medical Center

🇺🇸

Fort Hood, Texas, United States

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