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Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)

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ClinicalTrials.gov Identifier: NCT01435512
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Casey Taft, Boston VA Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE August 6, 2009
First Posted Date  ICMJE September 16, 2011
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2011)
Intimate partner aggression as measured by the conflict tactics scale [ Time Frame: 6-month follow up (after completion of treatment) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01435512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2011)
  • Symptoms of posttraumatic stress disorder as assessed by the Clinician Administered PTSD Scale (CAPS) and the Posttraumatic Stress Disorder Checklist (PCL) [ Time Frame: 6 month follow-up ]
  • Relationship satisfaction as measured by the Dyadic Adjustment Scale [ Time Frame: 6-month follow up ]
  • Trait anger as measured by the State-Trait Anger Expression Inventory (STAXI) and aggression as measured by the Aggression Questionnaire [ Time Frame: 6-month follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)
Official Title  ICMJE Strength At Home: Veterans' Program (Formerly: Post-Traumatic Stress Disorder (PTSD)-Focused Therapy for Anger and Relationship Conflict Among Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans)
Brief Summary This is a research study funded by the Department of Defense to test a therapeutic intervention for male combat veterans who engage in intimate partner violence (IPV). The investigators hope to decrease the recurrence of relationship aggression and help veterans manage anger. The primary aim of the study is to test the intervention.
Detailed Description The purpose of this project is to develop, standardize, and test an intervention for combat veterans exposed to trauma who engage in intimate partner aggression (IPA). This intervention, formerly labeled PTSD-Focused Cognitive Behavior Therapy for Partner Violence (PFCBT), and currently called the Strength at Home, Veteran's Program, incorporates components of interventions for IPA and trauma and will target mechanisms implicated in the relationship between trauma and IPA. This project addresses a number of the research gaps in this area of research including: (a) the development of a novel treatment approach to improve functioning and well-being of affected individuals; (b) tertiary prevention (of repeated IPA) during re-integration; and (c) examination of the efficacy of a program providing support for the families and caregivers of veterans with combat history.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Domestic Violence
Intervention  ICMJE Behavioral: PTSD-Focused CBT for Partner Violence
PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills.
Other Names:
  • Strength at Home
  • Veterans Program
Study Arms  ICMJE
  • Experimental: Group
    PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
    Intervention: Behavioral: PTSD-Focused CBT for Partner Violence
  • No Intervention: Waitlist
    Control group - no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
135
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2011)
120
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any era veteran
  • Over the age of 18
  • In a relationship within a female partner within the last 6 months
  • At least one act of male-to-female physical aggression over the previous 6 months or at least one act of male-to-female severe violence in the past 12 months
  • Male participant must consent for partner contact

Exclusion Criteria:

  • Participant evidences severe organicity or active psychosis
  • Reading difficulties prevent valid completion of the assessment instruments
  • Participant expresses prominent suicidal or homicidal ideation
  • Participant meets diagnostic criteria for alcohol and/or drug dependence, if not in early full remission or sustained partial remission
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01435512
Other Study ID Numbers  ICMJE PT073945
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Casey Taft, Boston VA Research Institute, Inc.
Study Sponsor  ICMJE Boston VA Research Institute, Inc.
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Casey T. Taft, PhD VA Boston Healthcare System
Principal Investigator: Suzannah Creech, PhD Providence VA Medical Center
PRS Account Boston VA Research Institute, Inc.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP