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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529435
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Brooke Army Medical Center
South Texas Veterans Health Care System
C.R.Darnall Army Medical Center
Central Texas Veterans Health Care System
VISN 17 Center of Excellence
University of Pennsylvania
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE January 27, 2017
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD
Official Title  ICMJE Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related Posttraumatic Stress Disorder
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Independent evaluators, who are blind to treatment condition, conduct semi-structured interviews to assess PTSD diagnosis at the posttreatment, three-month, and six-month follow-up assessments.
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder (PTSD)
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Massed Prolonged Exposure
  • 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.
    Intervention: Behavioral: Intensive Outpatient Prolonged Exposure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
235
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
230
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529435
Other Study ID Numbers  ICMJE W81XWH-13-2-0065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE
  • Brooke Army Medical Center
  • South Texas Veterans Health Care System
  • C.R.Darnall Army Medical Center
  • Central Texas Veterans Health Care System
  • VISN 17 Center of Excellence
  • University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Alan L Peterson, PhD University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP