Trial Outcomes & Findings for Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans) (NCT NCT01435512)
NCT ID: NCT01435512
Last Updated: 2020-09-16
Results Overview
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.
COMPLETED
NA
135 participants
Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks)
2020-09-16
Participant Flow
Participant milestones
| Measure |
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
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.
|
Waitlist
Control group - no intervention. Participants who were randomized to the waitlist at baseline were offered PTSD-Focused Cognitive Behavioral Therapy for Partner Violence after the 3-month follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
67
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)
Baseline characteristics by cohort
| Measure |
Group
n=67 Participants
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
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.
|
Waitlist
n=68 Participants
Control group - no intervention
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
38.2 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
37.85 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=93 Participants
|
68 participants
n=4 Participants
|
135 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group
n=67 Participants
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
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.
|
Waitlist
n=68 Participants
Control group - no intervention
|
|---|---|---|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Follow up Psychological IPV
|
3.04 Mean CTS Score
Interval 2.35 to 3.73
|
3.69 Mean CTS Score
Interval 3.11 to 4.26
|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Pretreatment Physical IPV
|
2.82 Mean CTS Score
Interval 2.19 to 3.45
|
2.51 Mean CTS Score
Interval 1.9 to 3.13
|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Posttreatment Physical IPV
|
0.71 Mean CTS Score
Interval 0.33 to 1.1
|
1.69 Mean CTS Score
Interval 1.01 to 2.38
|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Follow up Physical IPV
|
0.80 Mean CTS Score
Interval 0.18 to 1.41
|
0.80 Mean CTS Score
Interval 0.37 to 1.23
|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Pretreatment Psychological IPV
|
4.43 Mean CTS Score
Interval 3.87 to 5.0
|
4.46 Mean CTS Score
Interval 3.94 to 4.99
|
|
Intimate Partner Aggression as Measured by the Conflict Tactics Scale
Posttreatment Psychological IPV
|
2.81 Mean CTS Score
Interval 2.21 to 3.41
|
3.87 Mean CTS Score
Interval 3.2 to 4.54
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group
n=67 Participants
PTSD-Focused Cognitive Behavioral Therapy for Partner Violence
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.
|
Waitlist
n=68 Participants
Control group - no intervention
|
|---|---|---|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Dominance/Intimidation Followup
|
1.91 MMEA Scores
Interval 1.29 to 2.53
|
1.92 MMEA Scores
Interval 1.37 to 2.46
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Restrictive Engulfment Pretreatment
|
3.47 MMEA Scores
Interval 2.89 to 4.05
|
3.93 MMEA Scores
Interval 3.4 to 4.45
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Restrictive Engulfment Posttreatment
|
2.11 MMEA Scores
Interval 1.54 to 2.68
|
3.35 MMEA Scores
Interval 2.73 to 3.97
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Restrictive Engulfment Follow Up
|
1.80 MMEA Scores
Interval 1.21 to 2.38
|
3.24 MMEA Scores
Interval 2.61 to 3.86
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Denigration Pretreatment
|
3.21 MMEA Scores
Interval 2.66 to 3.76
|
3.49 MMEA Scores
Interval 2.9 to 4.07
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Denigration Posttreatment
|
1.80 MMEA Scores
Interval 1.23 to 2.36
|
2.82 MMEA Scores
Interval 2.19 to 3.45
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Denigration Followup
|
2.35 MMEA Scores
Interval 1.68 to 3.02
|
2.51 MMEA Scores
Interval 1.89 to 3.13
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Hostile Withdrawal Pretreatment
|
5.63 MMEA Scores
Interval 5.14 to 6.12
|
5.84 MMEA Scores
Interval 5.38 to 6.29
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Hostile Withdrawal Posttreatment
|
4.1 MMEA Scores
Interval 3.39 to 4.82
|
4.95 MMEA Scores
Interval 4.24 to 5.65
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Hostile Withdrawal Follow up
|
3.94 MMEA Scores
Interval 3.22 to 4.67
|
5.03 MMEA Scores
Interval 4.41 to 5.66
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Dominance/Intimidation Pretreatment
|
3.79 MMEA Scores
Interval 3.22 to 4.37
|
3.46 MMEA Scores
Interval 2.89 to 4.02
|
|
Multidimensional Measure of Emotional Abuse (MMEA)
MMEA Dominance/Intimidation Posttreatment
|
2.20 MMEA Scores
Interval 1.61 to 2.79
|
2.64 MMEA Scores
Interval 2.01 to 3.27
|
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
PTSD-Focused Cognitive Behavioral Therapy Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place