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

PTSD Clinical Trial

— MPTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228539
• Other study ID #: MPTSD-10-118-2
• Secondary ID: DOJ-2009-D1BX029
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: May 9, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Anger
• PTSD

Intervention

Behavioral:
• TARGET (Trauma Affect Regulation)
TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
• Prolonged Exposure
Cognitive behavior therapy with trauma memory exposure

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of PTSD symptoms	Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale	Post-therapy	No
Secondary	Anger/aggression problems	State-Trait Anger Expression Inventory Brief Symptom Inventory	Post-therapy	No
Secondary	Emotion Regulation	Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire	Post-therapy	No