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

Not Applicable

Completed

• Conditions: PTSD; Anger; Aggression
• Interventions: Behavioral: TARGET (Trauma Affect Regulation); Behavioral: Prolonged Exposure

• Registration Number: NCT01228539
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TARGET	TARGET (Trauma Affect Regulation)	Affect regulation psychotherapy for PTSD
Prolonged Exposure	Prolonged Exposure	Cognitive behavioral therapy for PTSD with trauma memory exposure

Primary Outcome Measures

Name	Time	Method
Severity of PTSD symptoms	Post-therapy	Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States