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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01435512
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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
Results First Submitted Date  ICMJE July 14, 2017
Results First Posted Date  ICMJE September 16, 2020
Last Update Posted Date September 16, 2020
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: August 27, 2020)
Intimate Partner Aggression as Measured by the Conflict Tactics Scale [ Time Frame: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks) ]
Revised Conflict Tactics Scale-2 (CTS2). The CTS2 is the most widely used measure of IPV, with excellent internal consistency reliability, content validity, and construct validity.76,88 Combined partner reports will be used such that scores of partners who report a greater frequency of specific CTS2 behaviors will be used in analyses to reduce the impact of response biases and the underreporting of abuse. The CTS2 will also be given every four weeks during the course of active intervention. Scale response options range from 0 to 7. Higher overall scores mean more conflict.
Original 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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Multidimensional Measure of Emotional Abuse (MMEA) [ Time Frame: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks) ]
    Change of physical and psychological IPV as evidenced by reduction in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
  • 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 (72 weeks) ]
    PTSD was used as a predictor instead of an outcome measure to determine if PTSD status was associated with poorer treatment response compared to the treatment as usual group. Refer to Creech and colleagues (2017). The structured interview utilizing CAPS was used to assess the frequency and intensity of the PTSD symptoms. Response options range from 1 "Not at all" to 5 "Extremely" for a total symptom severity score range of 17-85. Higher scores indicate symptoms severity of PTSD. Creech, S. K., Macdonald, A., Benzer, J. K., Poole, G. M., Murphy, C. M., & Taft, C. T. (2017, July 20). PTSD Symptoms Predict Outcome in Trauma-Informed Treatment of Intimate Partner Aggression. Journal of Consulting and Clinical Psychology. http://dx.doi.org/10.1037/ccp0000228
  • Relationship Satisfaction as Measured by the Dyadic Adjustment Scale [ Time Frame: 6-month follow up (72 weeks) ]
    Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
  • 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 (72 weeks) ]
    57 items assessing the intensity of anger as an emotional state (State Anger) and the tendency of an individual to experience state anger, or anger proneness (Trait Anger). The Trait Anger scale measures individual differences in the disposition to experience anger. The Anger Expression scale provides an index of the frequency of anger expression. Response options are 1 (not at all/hardly ever), 2 (somewhat/sometimes), or 3 (Very Much/Often). There are several subscales and, in general, higher scores indicate great feelings of anger, more likely to express anger, etc.
Original 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 ]
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
Current Responsible Party Casey Taft, Boston VA Research Institute, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boston VA Research Institute, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Casey T. Taft, PhD VA Boston Healthcare System
Principal Investigator: Suzannah Creech, PhD VA VISN 17 Center of Excellence
PRS Account Boston VA Research Institute, Inc.
Verification Date August 2020

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