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

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Julian Ford, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01228539
First received: September 22, 2010
Last updated: May 9, 2013
Last verified: May 2013

September 22, 2010
May 9, 2013
January 2010
December 2012   (final data collection date for primary outcome measure)
Severity of PTSD symptoms [ Time Frame: Post-therapy ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Anger/aggression problems [ Time Frame: Post-therapy ] [ Designated as safety issue: No ]
    State-Trait Anger Expression Inventory Brief Symptom Inventory
  • Emotion Regulation [ Time Frame: Post-therapy ] [ Designated as safety issue: No ]
    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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01228539
MPTSD-10-118-2, DOJ-2009-D1BX0299
Yes
Julian Ford, University of Connecticut Health Center
University of Connecticut Health Center
University of Pennsylvania
Principal Investigator: Julian Ford, Ph.D. University of Connecticut Health Center
University of Connecticut Health Center
May 2013

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