An interventional study of PTSD-Focused CBT for Partner Violence in Domestic Violence, sponsored by Boston VA Research Institute, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Boston VA Research Institute, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Boston VA Research Institute, Inc. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
Behavioral: PTSD-Focused CBT for Partner Violence
Control group - no intervention
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.
Also known as: Strength at Home, Veterans Program
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.
Time frame: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks)
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6-month follow up (72 weeks)
| Milestone | PTSD-Focused Cognitive Behavioral Therapy for Partner Violence | Waitlist |
|---|---|---|
| Started | 67 | 68 |
| Completed | 67 | 68 |
| Not completed | 0 | 0 |
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.
| Mean CTS Score | Group | Waitlist |
|---|---|---|
| Pretreatment Physical IPV | 2.82 (2.19 to 3.45) | 2.51 (1.9 to 3.13) |
| Posttreatment Physical IPV | 0.71 (0.33 to 1.1) | 1.69 (1.01 to 2.38) |
| Follow up Physical IPV | 0.80 (0.18 to 1.41) | 0.80 (0.37 to 1.23) |
| Pretreatment Psychological IPV | 4.43 (3.87 to 5.0) | 4.46 (3.94 to 4.99) |
| Posttreatment Psychological IPV | 2.81 (2.21 to 3.41) | 3.87 (3.2 to 4.54) |
| Follow up Psychological IPV | 3.04 (2.35 to 3.73) | 3.69 (3.11 to 4.26) |
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.
| MMEA Scores | Group | Waitlist |
|---|---|---|
| MMEA Restrictive Engulfment Pretreatment | 3.47 (2.89 to 4.05) | 3.93 (3.40 to 4.45) |
| MMEA Restrictive Engulfment Posttreatment | 2.11 (1.54 to 2.68) | 3.35 (2.73 to 3.97) |
| MMEA Restrictive Engulfment Follow Up | 1.80 (1.21 to 2.38) | 3.24 (2.61 to 3.86) |
| MMEA Denigration Pretreatment | 3.21 (2.66 to 3.76) | 3.49 (2.9 to 4.07) |
| MMEA Denigration Posttreatment | 1.80 (1.23 to 2.36) | 2.82 (2.19 to 3.45) |
| MMEA Denigration Followup | 2.35 (1.68 to 3.02) | 2.51 (1.89 to 3.13) |
| MMEA Hostile Withdrawal Pretreatment | 5.63 (5.14 to 6.12) | 5.84 (5.38 to 6.29) |
| MMEA Hostile Withdrawal Posttreatment | 4.1 (3.39 to 4.82) | 4.95 (4.24 to 5.65) |
| MMEA Hostile Withdrawal Follow up | 3.94 (3.22 to 4.67) | 5.03 (4.41 to 5.66) |
| MMEA Dominance/Intimidation Pretreatment | 3.79 (3.22 to 4.37) | 3.46 (2.89 to 4.02) |
| MMEA Dominance/Intimidation Posttreatment | 2.20 (1.61 to 2.79) | 2.64 (2.01 to 3.27) |
| MMEA Dominance/Intimidation Followup | 1.91 (1.29 to 2.53) | 1.92 (1.37 to 2.46) |
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PTSD-Focused Cognitive Behavioral Therapy Group | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Control Group | 0/68 (0%) | 0/68 (0%) | 0/68 (0%) |
| Age, Categorical(Participants) | Group | Waitlist | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 67 | 68 | 135 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Group | Waitlist | Total |
|---|---|---|---|
| Mean | 37.5 ± 12.9 | 38.2 ± 12.7 | 37.85 ± 12.8 |
| Sex: Female, Male(Participants) | Group | Waitlist | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 67 | 68 | 135 |
| Region of Enrollment(participants) | Group | Waitlist | Total |
|---|---|---|---|
| United States | 67 | 68 | 135 |
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Boston VA Research Institute, Inc.