- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435512
Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- National Center for PTSD/VA Boston Healthcare System
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908
- Providence VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group
PTSD-Focused Cognitive Behavioral Therapy 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:
|
|
NO_INTERVENTION: Waitlist
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
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.
|
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)
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.
|
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)
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 |
6 month follow-up (72 weeks)
|
|
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.
|
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
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. |
6-month follow up (72 weeks)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Casey T. Taft, PhD, VA Boston Healthcare System
- Principal Investigator: Suzannah Creech, PhD, VA VISN 17 Center of Excellence
Publications and helpful links
General Publications
- 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.
- Creech SK, Macdonald A, Benzer JK, Poole GM, Murphy CM, Taft CT. PTSD symptoms predict outcome in trauma-informed treatment of intimate partner aggression. J Consult Clin Psychol. 2017 Oct;85(10):966-974. doi: 10.1037/ccp0000228. Epub 2017 Jul 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PT073945
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Domestic Violence
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
University of PittsburghCompletedViolence in Adolescence | Domestic ViolenceUnited States
-
University of SheffieldUniversity of HuddersfieldCompleted
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedViolence, Domestic | Violence-Related SymptomUnited States
Clinical Trials on PTSD-Focused CBT for Partner Violence
-
McMaster UniversityEcho: Improving Women's Health in Ontario (formerly Ontario Women's Health...CompletedIntimate Partner Violence Against WomenCanada
-
University Health Network, TorontoCompletedEating Disorder | PostTraumatic Stress DisorderCanada
-
Medical University of South CarolinaAgency for Healthcare Research and Quality (AHRQ)Completed
-
VU University of AmsterdamUnknownSubstance Abuse | Domestic ViolenceNetherlands
-
VU University of AmsterdamCompletedSubstance-Related Disorders | Stress Disorders, Post-TraumaticNetherlands
-
University of TwenteCompletedPosttraumatic Stress DisorderNetherlands
-
Black Hills Center for American Indian HealthYale UniversityRecruitingSmoking Cessation | Cigarette SmokingUnited States
-
University of North Carolina, Chapel HillCompletedPosttraumatic Stress Disorder | Substance AbuseUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute on Drug Abuse (NIDA); Brown University; Providence VA Medical...CompletedSubstance-Related Disorders | Stress Disorder, Post-TraumaticUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Stress Disorders, Post-TraumaticUnited States