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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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PTSD, Anger, Aggression

Intervention / Treatment
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* Behavioral: TARGET (Trauma Affect Regulation)
* Behavioral: Prolonged Exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TARGET<br>Affect regulation psychotherapy for PTSD | Behavioral: TARGET (Trauma Affect Regulation)<br>* TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.<br>* Other names: TARGET;|
| Active Comparator: Prolonged Exposure<br>Cognitive behavioral therapy for PTSD with trauma memory exposure | Behavioral: Prolonged Exposure<br>* Cognitive behavior therapy with trauma memory exposure<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Anger, Aggression, Military