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Completed

NCT Number: NCT02313818

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Processing Therapy-Cognitive Only

Behavioral

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.

Primary outcomes

  1. Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)

    Time frame: 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.

  2. Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)

    Time frame: 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 outcomes

  1. Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9

    Time frame: Pretreatment, 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boston VA Research Institute, Inc.
  • STRONG STAR Consortium
  • The University of Texas Health Science Center at San Antonio

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2014
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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