Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
MPTSD
2 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 13, 2013
May 1, 2013
2.9 years
September 22, 2010
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of PTSD symptoms
Clinician Administered PTSD Scale Ordinal Scores Posttraumatic Cognitions Inventory Trauma Memory Questionnaire Interpretation of PTSD Symptoms Scale
Post-therapy
Secondary Outcomes (2)
Anger/aggression problems
Post-therapy
Emotion Regulation
Post-therapy
Study Arms (2)
TARGET
EXPERIMENTALAffect regulation psychotherapy for PTSD
Prolonged Exposure
ACTIVE COMPARATORCognitive behavioral therapy for PTSD with trauma memory exposure
Interventions
TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
Cognitive behavior therapy with trauma memory exposure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- currently be danger of suicide
- currently abusing alcohol or other substances
- been in an inpatient psychiatric or addiction treatment program in the past month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- University of Pennsylvaniacollaborator
Study Sites (1)
University of Connecticut Health Center
Farmington, Connecticut, 06030-1410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julian Ford, Ph.D.
UConn Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2010
First Posted
October 26, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 13, 2013
Record last verified: 2013-05