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

NCT ID: NCT01228539

Last Updated: 2013-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

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.

Conditions

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PTSD Anger Aggression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TARGET

Affect regulation psychotherapy for PTSD

Group Type EXPERIMENTAL

TARGET (Trauma Affect Regulation)

Intervention Type BEHAVIORAL

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

Prolonged Exposure

Cognitive behavioral therapy for PTSD with trauma memory exposure

Group Type ACTIVE_COMPARATOR

Prolonged Exposure

Intervention Type BEHAVIORAL

Cognitive behavior therapy with trauma memory exposure

Interventions

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TARGET (Trauma Affect Regulation)

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

Intervention Type BEHAVIORAL

Prolonged Exposure

Cognitive behavior therapy with trauma memory exposure

Intervention Type BEHAVIORAL

Other Intervention Names

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TARGET

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Julian Ford

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julian Ford, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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DOJ-2009-D1BX0299

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MPTSD-10-118-2

Identifier Type: -

Identifier Source: org_study_id

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