Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study (MPTSD)

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. Identifier: NCT01228539
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : May 13, 2013
University of Pennsylvania
Information provided by (Responsible Party):
Julian Ford, UConn Health

September 22, 2010
October 26, 2010
May 13, 2013
January 2010
December 2012   (Final data collection date for primary outcome measure)
Severity of PTSD symptoms [ Time Frame: Post-therapy ]
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
Same as current
Complete list of historical versions of study NCT01228539 on Archive Site
  • Anger/aggression problems [ Time Frame: Post-therapy ]
    State-Trait Anger Expression Inventory Brief Symptom Inventory
  • Emotion Regulation [ Time Frame: Post-therapy ]
    Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire
Same as current
Not Provided
Not Provided
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with PTSD and problems with anger after returning from military service in Afghanistan (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused PE psychotherapy.
The study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in Iraq or Afghanistan. Trauma exposure places personnel at risk for PTSD, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. The two types of treatments being compared, TARGET (Trauma Affect Regulation: Guide for Education and Therapy) and PE (Prolonged Exposure), are both designed to directly reduce PTSD severity by reducing emotion dysregulation (TARGET) and experiential avoidance (PE), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • PTSD
  • Anger
  • Aggression
  • Behavioral: TARGET (Trauma Affect Regulation)
    TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
    Other Name: TARGET
  • Behavioral: Prolonged Exposure
    Cognitive behavior therapy with trauma memory exposure
  • Experimental: TARGET
    Affect regulation psychotherapy for PTSD
    Intervention: Behavioral: TARGET (Trauma Affect Regulation)
  • Active Comparator: Prolonged Exposure
    Cognitive behavioral therapy for PTSD with trauma memory exposure
    Intervention: Behavioral: Prolonged Exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • be a returning OEF/OIF military personnel or veteran
  • have experienced PTSD for the past month
  • have experienced anger and at least one act of aggression in the last month
  • be mentally able to provide a valid consent

Exclusion Criteria:

  • currently be danger of suicide
  • currently abusing alcohol or other substances
  • been in an inpatient psychiatric or addiction treatment program in the past month
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
DOJ-2009-D1BX0299 ( Other Grant/Funding Number: National Institute of Justice, Department of Justice )
Not Provided
Not Provided
Julian Ford, UConn Health
UConn Health
University of Pennsylvania
Principal Investigator: Julian Ford, Ph.D. UConn Health
UConn Health
May 2013

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