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Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02313818
Enrollment
130
Registered
2014-12-10
Start date
2015-06-30
Completion date
2018-12-31
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Variable length Cognitive Processing Therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatmentThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026