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OpenTrials
Completed

NCT Number: NCT01228539

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.

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Key information

Conditions

PTSD Aberrant Motor Behavior in Dementia Aggression Anger Behavior Behavioral Symptoms Mental Disorders Social Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-1410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TARGET (Trauma Affect Regulation)

Behavioral

TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.

Other names: TARGET

Prolonged Exposure

Behavioral

Cognitive behavior therapy with trauma memory exposure

Primary outcomes

  1. Severity of PTSD symptoms

    Time frame: Post-therapy

    Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale

Secondary outcomes

  1. Anger/aggression problems

    Time frame: Post-therapy

    State-Trait Anger Expression Inventory Brief Symptom Inventory

  2. Emotion Regulation

    Time frame: Post-therapy

    Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • University of Pennsylvania

Registry information

Acronym: MPTSD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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