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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PTSD Anger Aggression Behavioral: TARGET (Trauma Affect Regulation) Behavioral: Prolonged Exposure Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TARGET
Affect regulation psychotherapy for PTSD
Behavioral: TARGET (Trauma Affect Regulation)
TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
Other Name: TARGET

Active Comparator: Prolonged Exposure
Cognitive behavioral therapy for PTSD with trauma memory exposure
Behavioral: Prolonged Exposure
Cognitive behavior therapy with trauma memory exposure

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Anger/aggression problems [ Time Frame: Post-therapy ]
    State-Trait Anger Expression Inventory Brief Symptom Inventory

  2. Emotion Regulation [ Time Frame: Post-therapy ]
    Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire

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:   Male
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01228539

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1410
Sponsors and Collaborators
UConn Health
University of Pennsylvania
Principal Investigator: Julian Ford, Ph.D. UConn Health

Responsible Party: Julian Ford, Professor, UConn Health Identifier: NCT01228539     History of Changes
Other Study ID Numbers: MPTSD-10-118-2
DOJ-2009-D1BX0299 ( Other Grant/Funding Number: National Institute of Justice, Department of Justice )
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Julian Ford, UConn Health:

Additional relevant MeSH terms:
Behavioral Symptoms