Domestic Violence Clinical Trial
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)
NCT number | NCT01435512 |
Other study ID # | PT073945 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2009 |
Est. completion date | September 2014 |
Verified date | August 2020 |
Source | Boston VA Research Institute, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | National Center for PTSD/VA Boston Healthcare System | Boston | Massachusetts |
United States | Providence VA Medical Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Boston VA Research Institute, Inc. | United States Department of Defense |
United States,
Taft CT, Macdonald A, Creech SK, Monson CM, Murphy CM. A Randomized Controlled Clinical Trial of the Strength at Home Men's Program for Partner Violence in Military Veterans. J Clin Psychiatry. 2016 Sep;77(9):1168-1175. doi: 10.4088/JCP.15m10020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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