Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study (MPTSD)
Primary Purpose
PTSD, Anger, Aggression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TARGET (Trauma Affect Regulation)
Prolonged Exposure
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Anger, Aggression, Military
Eligibility 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
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TARGET
Prolonged Exposure
Arm Description
Affect regulation psychotherapy for PTSD
Cognitive behavioral therapy for PTSD with trauma memory exposure
Outcomes
Primary Outcome Measures
Severity of PTSD symptoms
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
Secondary Outcome Measures
Anger/aggression problems
State-Trait Anger Expression Inventory Brief Symptom Inventory
Emotion Regulation
Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire
Full Information
NCT ID
NCT01228539
First Posted
September 22, 2010
Last Updated
May 9, 2013
Sponsor
UConn Health
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01228539
Brief Title
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Acronym
MPTSD
Official Title
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Anger, Aggression
Keywords
PTSD, Anger, Aggression, Military
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TARGET
Arm Type
Experimental
Arm Description
Affect regulation psychotherapy for PTSD
Arm Title
Prolonged Exposure
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy for PTSD with trauma memory exposure
Intervention Type
Behavioral
Intervention Name(s)
TARGET (Trauma Affect Regulation)
Other Intervention Name(s)
TARGET
Intervention Description
TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Description
Cognitive behavior therapy with trauma memory exposure
Primary Outcome Measure Information:
Title
Severity of PTSD symptoms
Description
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
Time Frame
Post-therapy
Secondary Outcome Measure Information:
Title
Anger/aggression problems
Description
State-Trait Anger Expression Inventory Brief Symptom Inventory
Time Frame
Post-therapy
Title
Emotion Regulation
Description
Negative Mood Regulation scale Difficulty with Emotion Regulation Scale Acceptance and Action Questionnaire
Time Frame
Post-therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Ford, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
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