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

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.

Study Overview

• Status: Completed
• Conditions: Anger; Aggression; PTSD
• Intervention / Treatment: Behavioral: TARGET (Trauma Affect Regulation); Behavioral: Prolonged Exposure

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
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030-1410
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: TARGET
Active Comparator: Prolonged Exposure; Cognitive behavioral therapy for PTSD with trauma memory exposure	Behavioral: Prolonged Exposure; Cognitive behavior therapy with trauma memory exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of PTSD symptoms	Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale	Post-therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anger/aggression problems	State-Trait Anger Expression Inventory Brief Symptom Inventory	Post-therapy
Emotion Regulation	Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire	Post-therapy

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: PTSD; Anger; Aggression; Military
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: MPTSD-10-118-2; DOJ-2009-D1BX0299 (Other Grant/Funding Number: National Institute of Justice, Department of Justice)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No