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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
History of Changes
  Purpose

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 Intervention
PTSD
Anger
Aggression
 Behavioral: TARGET (Trauma Affect Regulation)
Behavioral: Prolonged Exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study

Resource links provided by NLM:

MedlinePlus related topics: Injuries Memory Wounds
U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 31
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228539

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

No publications provided

Responsible Party: Julian Ford, Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01228539     History of Changes
Other Study ID Numbers: MPTSD-10-118-2, DOJ-2009-D1BX0299
Study First Received: September 22, 2010
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
PTSD
Anger
Aggression
Military

Additional relevant MeSH terms:
Aggression
Stress Disorders, Post-Traumatic
Behavioral Symptoms
 Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013