Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD

August 5, 2022 updated by: The University of Texas Health Science Center at San Antonio

Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related Posttraumatic Stress Disorder

The study compares two intensive outpatient behavioral programs (Massed Prolonged Exposure versus Intensive Outpatient Prolonged Exposure) for the treatment of posttraumatic stress disorder (PTSD) in post-9/11 active duty service members and veterans. The researchers hope to learn if these programs improve treatment outcomes. The researchers predict that Intensive Outpatient Prolonged Exposure (IOP-PE) will be better at treating PTSD than Massed-Prolonged Exposure (Massed PE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With an estimated 200,000 - 600,000 post-9/11 service members and veterans suffering from combat-related posttraumatic stress disorder (PTSD; 7-20% of the 3 million who have deployed), there is an urgent need for accessible therapies that are highly effective in quickly treating PTSD to remission, enabling service members to stay fit for active duty and veterans to integrate well into civilian life. While combat-related PTSD can be successfully treated in post-9/11 active duty service members and veterans, recent studies indicate that they do not derive the same degree of benefit from evidence-based behavioral treatments (e.g., Prolonged Exposure; Cognitive Processing Therapy) as their civilian counterparts. This suggests that combat-related PTSD is uniquely different from PTSD in civilians and that treatments are needed that expand and augment established evidence-based treatments in order to address the distinctive elements of combat-related traumas.

Prolonged Exposure (PE) is the PTSD treatment most extensively evaluated in clinical trials with civilians and veterans, and there is strong scientific evidence to support its efficacy. In standard outpatient PE, patients participate in weekly session over the course of two to three months. However, given military work requirements, participation in standard outpatient services is not always feasible. In the largest PE study with post-911 active duty service members to date conducted by Foa and colleagues in 2018 found PE delivered in a massed format (i.e., ten 90-minute PE sessions delivered on weekdays over 2 weeks) results in similar treatment outcomes to those of PE delivered in the standard spaced format (i.e., ten 90-minute PE sessions delivered over 8 weeks).

The current study expands and augments the previous treatment protocol. More specifically, this study examines whether intensive PE protocols can improve on treatment outcomes for post-9/11 service members and veterans with combat-related PTSD. The purpose of this randomized clinical trial is to compare the efficacy Massed-Prolonged Exposure (Massed-PE, 15 90-minute sessions delivered over three weeks) versus Intensive Outpatient Prolonged Exposure protocol (IOP-PE, 15 days of treatment delivered over three weeks). In comparison with the Massed PE examined by Foa, Massed-PE in this study has been modified to include 50% more sessions and release from duty. IOP-PE has been further augmented and includes the following modifications: (1) the use of a team-based treatment approach; (2) clinic-based completion of daily homework assignments; (3) brief therapist feedback sessions after daily homework assignments; (4) enhanced social support; (5) focusing on patients' three most distressing traumas during imaginal exposure; (6) graduated imaginal exposure starting with the least distressing trauma; (7) an optional telescopic, brief, timeline review of all traumatic events that occurred during previous deployments; and (8) the completion of three posttreatment booster sessions. Up to 400 post-9/11 active duty military and veterans will be consented to obtain data from 230 for analysis. The main outcomes of the study include PTSD diagnoses and symptom severity as measured by the Clinician Administered PTSD Scale for the (CAPS-5) and the PTSD Checklist-for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition(PCL-5). Participants will be assessed at baseline, while in-treatment and at one-, three-, and six-months after treatment completion. The researchers predict that IOP-PE will result in larger reductions than the Massed-PE in PTSD symptoms at the three follow-up assessments.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Carl R. Darnall Army Medical Center
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Health Care System
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center
      • Waco, Texas, United States, 76504
        • Central Texas Veterans Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Active duty military service member or veteran (age 18- 65 years) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD.
  2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5).
  3. Able to speak and read English (due to standardization of outcome measures)

Exclusion Criteria:

  1. Current manic episode or a psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the MINI).
  2. Current and severe alcohol use warranting immediate intervention based on clinical judgment.
  3. Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires).
  4. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider)
  5. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Massed Prolonged Exposure
Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.
Behavioral: Massed Prolonged Exposure
Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.
Experimental: Intensive Outpatient Prolonged Exposure
The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.
Behavioral: Intensive Outpatient Prolonged Exposure
The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD symptoms
Time Frame: Baseline to 4 Weeks (Posttreatment)
Change in scale measurements by the Clinician Administered PTSD Scale (CAPS-5). The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Total Score (Range 0-80 with higher scores representing more PTSD symptoms)
Baseline to 4 Weeks (Posttreatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

University of Pennsylvania
Brooke Army Medical Center
C.R.Darnall Army Medical Center
South Texas Veterans Health Care System
Central Texas Veterans Health Care System
VISN 17 Center of Excellence

Investigators

  • Principal Investigator: Alan L Peterson, PhD, University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2017

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-13-2-0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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