Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313818
• Other study ID #: Pro00062853
• Secondary ID: W81XWH-13-2-0012
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Processing Therapy-Cognitive Only
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.

Locations

Country	Name	City	State
United States	Carl R Darnall Army Medical Center	Fort Hood	Texas

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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