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

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: PTSD-Focused CBT for Partner Violence


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group<br>PTSD-Focused Cognitive Behavioral Therapy for Partner Violence | Behavioral: PTSD-Focused CBT for Partner Violence<br>* 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.<br>* Other names: Veterans Program;|
| No Intervention: Waitlist<br>Control group - no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intimate Partner Aggression as Measured by the Conflict Tactics Scale | 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. | Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Measure of Emotional Abuse (MMEA) | 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. | Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks) | 
| Symptoms of Posttraumatic Stress Disorder as Assessed by the Clinician Administered PTSD Scale (CAPS) and the Posttraumatic Stress Disorder Checklist (PCL) | 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 | 6 month follow-up (72 weeks) | 
| Relationship Satisfaction as Measured by the Dyadic Adjustment Scale | 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. | 6-month follow up (72 weeks) | 
| Trait Anger as Measured by the State-Trait Anger Expression Inventory (STAXI) and Aggression as Measured by the Aggression Questionnaire | 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. | 6-month follow up (72 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, CBT, Intimate Partner Violence, Treatment