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Domestic ViolenceNCT01435512

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

A study testing PTSD-Focused CBT for Partner Violence in people with Domestic Violence, run by Boston VA Research Institute, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Domestic Violence
What is being tested?
PTSD-Focused CBT for Partner Violence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
2 sitesUnited States
Study dates
Mar 2009to Sep 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Center for PTSD/VA Boston Healthcare System

    Boston, Massachusetts, 02130

  • Providence VA Medical Center

    Providence, Rhode Island, 02908

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
PTSD-Focused CBT for Partner Violence
Keywords
PTSD, CBT, Intimate Partner Violence, Treatment
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTSD-Focused CBT for Partner ViolenceBehavioural

    Also called Strength at Home, Veterans Program

    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.

Study groups in NCT01435512
Study groupRoleWhat they receive
GroupExperimentalPTSD-Focused Cognitive Behavioral Therapy for Partner Violence
Receives: Behavioral: PTSD-Focused CBT for Partner Violence
WaitlistNo interventionControl group - no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks)

Secondary outcomes (4)

  1. 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.

    Measured: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks)

  2. 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

    Measured: 6 month follow-up (72 weeks)

  3. 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.

    Measured: 6-month follow up (72 weeks)

  4. 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.

    Measured: 6-month follow up (72 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2011 (estimated)
  2. Study startMar 2009
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435512
Sponsor's protocol ID
PT073945
Status last verified
Aug 2020
First submitted
6 Aug 2009
Last updated
16 Sep 2020
Data monitoring committee
Yes

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.

    PubMed 26613288

  • 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.

    PubMed 28726440

Questions about this trial

What is this clinical trial studying?

A study testing PTSD-Focused CBT for Partner Violence in people with Domestic Violence, run by Boston VA Research Institute, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intimate Partner Aggression as Measured by the Conflict Tactics Scale (time frame: Pretreatment (baseline), Posttreatment (12 weeks), 3 month follow up (24 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435512, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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