Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy-Cognitive Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Variable length Cognitive Processing Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPT-C<br>Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning. | Behavioral: Cognitive Processing Therapy-Cognitive Only<br>* Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for 4-24 sessions; each session is 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5) | PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor. | Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment | 
| Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5) | is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5 | Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9 | 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. | Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military