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Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy-Cognitive Only
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carl R Darnall Army Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPT-C

Arm Description

Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2014
Last Updated
January 15, 2019
Sponsor
Duke University
Collaborators
Boston VA Research Institute, Inc., The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02313818
Brief Title
Variable-length Cognitive Processing Therapy for Combat-Related PTSD
Official Title
Variable-length Cognitive Processing Therapy for Combat-Related PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Boston VA Research Institute, Inc., The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Variable length Cognitive Processing Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPT-C
Arm Type
Experimental
Arm Description
Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy-Cognitive Only
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)
Description
PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.
Time Frame
Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Title
Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)
Description
is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5
Time Frame
Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Secondary Outcome Measure Information:
Title
Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9
Description
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.
Time Frame
Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A Resick, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl R Darnall Army Medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29431455
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.
Results Reference
derived

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Variable-length Cognitive Processing Therapy for Combat-Related PTSD

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