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Massed Cognitive Processing Therapy for Combat-related PTSD

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ClinicalTrials.gov Identifier: NCT03808727
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Fort Belvoir Community Hospital
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Jennifer Schuster Wachen, Ph.D., VA Boston Healthcare System

Brief Summary:
The purpose of this study is to determine if cognitive processing therapy (CPT) delivered in a massed format (MCPT) is as effective as standard delivery of CPT. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment and 1 month and 4 months following treatment in both conditions. Additionally, in order to compare the treatment groups at the same point in actual time, each group will be assessed at the one month posttreatment time point for the other condition.

Condition or disease Intervention/treatment Phase
PTSD, Post Traumatic Stress Disorder Behavioral: Cognitive Processing Therapy Not Applicable

Detailed Description:

Cognitive Processing Therapy (CPT) is identified as one of the most effective treatments for posttraumatic stress disorder (PTSD) in a wide range of trauma populations, with a higher effect size than any other evidence-based treatments for PTSD. However, CPT has been shown to be somewhat less effective in active duty and veteran populations when compared to civilian trauma victims. One reason may be that service members have difficulty committing to a six-week course of therapy due to the demanding nature of active duty military operations schedules. In addition, limited availability of clinical providers may reduce access to care. One way to address these barriers may be to administer CPT in an intensive, 5-day format. This format may increase rates of treatment completion and produce faster symptom improvement than the standard administration of CPT. This study will test the efficacy of massed CPT (MCPT) compared to standard CPT delivery. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions.

The sample includes 140 active duty service members randomized to receive either MCPT or standard CPT. Participants will be assessed 4 times during the course of the study. In order to test the equivalence of the treatment conditions, outcomes will be compared at a consistent number of weeks posttreatment for each condition (e.g., at baseline, and one month and 4 months following the conclusion of the therapy). Additionally, in order to compare the treatment groups at the same point in actual time, each group will be assessed at the one month posttreatment time point for the other condition. The timing of these assessment intervals allows for the comparison groups to be assessed similarly at each important juncture of therapy (baseline and post-treatment) and also to be assessed for maintenance of treatment gains following a similar passage of time (4 months post-treatment). Those who drop out of treatment will be asked to return for the follow-up assessments based on their projected end date for inclusion in the intent to treat analyses.

Aim 1: To evaluate the efficacy of massed CPT in a sample of active duty military in reductions of clinician-rated and self-reported PTSD symptoms, as well as secondary outcomes including depression, psychosocial functioning, and physical health after treatment completion (assessed at one month and 4 months posttreatment for each condition). Rates of treatment completion and speed of recovery will also be compared between conditions.

Aim 2: To examine predictors of symptom reduction in each treatment condition including demographic characteristics, military factors, psychosocial variables, and comorbid mental health symptoms.

Aim 3 (Exploratory): To evaluate the tolerability of massed versus standard administration of CPT. Important nonspecific factors such as therapeutic alliance, patient preference, treatment expectancy, perceived burden, and emotional factors such as anxiety and avoidance will be examined with regard to treatment outcome.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Massed Cognitive Processing Therapy for Combat-related PTSD
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Massed Cognitive Processing Therapy (MCPT)
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions.
Behavioral: Cognitive Processing Therapy
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.

Active Comparator: Standard Cognitive Processing Therapy
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Standard CPT will be delivered in 12 one-hour sessions over 6 weeks and involves only individual sessions.
Behavioral: Cognitive Processing Therapy
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.




Primary Outcome Measures :
  1. Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The CAPS is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study.

  2. Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment ]
    The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD


Secondary Outcome Measures :
  1. Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment ]
    The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms

  2. Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment ]
    The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide.

  3. Changes in functioning as measured by the Well-Being Inventory (WBI) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The WBI provides a multidimensional assessment of status, functioning, and satisfaction in the four key life domains of vocation, finances, health, and social relationships.This study will only include the subscales measuring functioning and satisfaction in the domains of work, health, and social relationships.

  4. Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The AUDIT is a 10-item screening measure, developed by the World Health Organization (WHO), with three subscales (alcohol consumption, drinking behavior, and alcohol-related problems)

  5. Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The DAR-5 63 is a short form version of the original Dimensions of Anger Reactions. 64 It addresses anger frequency, intensity, duration, aggression, and interference with social functioning.

  6. Changes in health functioning as measured by the Veterans Rand 12-Item Health Survey (VR-12) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The Veterans VR-12 was developed from the Veterans VR-36 and adapted from the Short Form -36 (SF-36), and spans the range of health domains from physical to psychological health status.

  7. Change in somatic symptoms as measured by the Patient Health Questionnaire - 15 (PHQ-15) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The PHQ-15 70 is an abbreviated version of the original PHQ that asks about somatic symptoms and symptom clusters

  8. Change in sleep disturbance as measured by the Insomnia Severity Index (ISI) [ Time Frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) ]
    The ISI is a 7-item self-report measure that assesses perceived severity of insomnia.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female (age 18+) active duty military seeking treatment for PTSD
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808727


Contacts
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Contact: Jennifer S Wachen, Ph.D. 857-364-5444 jennifer.wachen@va.gov
Contact: Kris Morris, Ph.D. 571-231-1254 kristy.l.morris8.civ@mail.mil

Locations
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United States, Virginia
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Kris Morris, Ph.D.    571-231-1254    kristy.l.morris8.civ@mail.mil   
Contact: Jennifer Weaver, M.D.    571-231-4623    jennifer.j.weaver6.civ@mail.mil   
Sponsors and Collaborators
VA Boston Healthcare System
Fort Belvoir Community Hospital
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Jennifer Wachen, Ph.D. VA Boston Healthcare System

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Responsible Party: Jennifer Schuster Wachen, Ph.D., Principal Investigator, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT03808727     History of Changes
Other Study ID Numbers: W81XWH-17-2-0067
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Schuster Wachen, Ph.D., VA Boston Healthcare System:
cognitive processing therapy
CPT
PTSD
military

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders