Massed Cognitive Processing Therapy for Combat-related PTSD

NCT03808727 | Completed

• 1 other identifier: W81XWH-17-2-0067
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD, Post Traumatic Stress Disorder

Keywords

cognitive processing therapy; CPT; PTSD; military

Outcome Measures

Primary Outcomes (2)

• Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)

  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.

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment

Secondary Outcomes (8)

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment

• Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS)

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment

• Changes in functioning as measured by the Well-Being Inventory (WBI)

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)

• Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)

• Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5)

  Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)

Study Arms (2)

Massed Cognitive Processing Therapy (MCPT)

EXPERIMENTAL

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

Standard Cognitive Processing Therapy

ACTIVE COMPARATOR

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

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Massed Cognitive Processing Therapy (MCPT); Standard Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Boston Healthcare System: lead
• Fort Belvoir Community Hospital: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer Wachen, Ph.D.

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: March 5, 2019
• Primary Completion: May 13, 2022
• Study Completion: December 31, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)