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AggressionNCT00827879

Strength at Home Couples Program (PTSD-Focused Relationship Enhancement Therapy for Returning Veterans)

A study testing Strength at Home Couples Group and Supportive Group Therapy in people with Aggression and Post Traumatic Stress Disorders, 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

The purpose of the project is to develop and test a couples-based relationship enhancement group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate partner aggression (IPA) among participants. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Aggression, Post Traumatic Stress Disorders
What is being tested?
Strength at Home Couples Group and Supportive Group Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
2 sitesUnited States
Study dates
Feb 2009to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • couples must have been in a committed relationship for at least six months
  • veterans and their partners must be over the age of 18
  • male members of the couple report no occurrence of physical aggression during the last six months in their current relationship on the Revised Conflict Tactics Scale (CTS2; Straus et al, 1996)
  • female members of the couple may report that they have engaged in low level aggression during the past six months in their current relationship on the Revised Conflict Tactics Scale (CTS2; Straus et al., 1996)
  • one partner of the couple averages at or below a score of 29 on the 6-item Quality of Marriage Index (QMI; Norton, 1983) or a 100 or below on the Dyadic Adjustment Score (DAS; Spanier, 1976), which are cutoff scores often used to distinguish distressed and non-distressed couples (e.g., Slep, Heyman, Williams, Van Dyke, \& O'Leary, 2006), or one member of the couple endorses veteran-perpetrated psychological aggression (defined as scoring above the 75%ile on the CTS2 minor psychological aggression subscale, or any endorsement of items on the severe psychological aggression subscale on the CTS2 or the Dominance/Intimidation scale of the Multidimensional Measure of Emotional Abuse, MMEA; Murphy \& Hoover, 1999;)
  • both members of the couple provide research consent

Who cannot join

  • reading difficulties prevent valid completion of the assessment instruments
  • the participant evidences severe organicity or active psychosis
  • the participant expresses prominent suicidal or homicidal ideation
  • the participant meets diagnostic criteria for alcohol and/or drug dependence, if not in early full remission or sustained partial remission
  • female members of the couple report their violence includes the use of weapons during the past six months in their current relationship on the Revised Conflict Tactics Scale (CTS2; Straus et al., 1996)
  • violence perpetrated by female members of the couple produces injuries in men
Show all 9Show fewer
  • male members of the couple indicate they are fearful of the female partner
  • male members of the couple report they are physically violent in any way during the past six months or severely violent in the past 12 months of their current relationship on the Revised Conflict Tactics Scale (CTS2; Straus et al., 1996)
  • male members of the couple have had any bruising or injuries inflicted by the female partner during the past six months in their current relationship. Criteria b through d will be assessed using the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and clinical interview

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 Couples Program (Formerly: PTSD-Focused Relationship Enhancement Therapy for Returning Veterans and Their Partners)

The purpose of the project is to develop and test a couples-based relationship enhancement group intervention for married or partnered Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) veterans to prevent the perpetration of intimate partner aggression (IPA) among participants.

Read the detailed description

The focus of this project is to produce a well-defined and standardized intervention, labeled Strength at Home Couples Group, that can improve intimate relationship satisfaction, decrease the likelihood of relationship aggression, increase the intimacy and closeness of the relationship, and help with anger management. We hope to learn more about how to improve relationships, how to prevent anger and violence, and about what factors help people successfully complete treatment. Strength at Home Couples Group will incorporate components of several interventions for PTSD and IPA and will target mechanisms implicated in the PTSD-IPA association. The development of this type of integrated intervention is critical due to high rates of PTSD-IPA co-occurrence and the pressing need to efficiently address both problems among military veterans. Specific aims of this project are: (1) to develop and standardize Strength at Home Couples Group for male combat veterans, including the development of a clinician-friendly intervention manual detailing Strength at Home Couples Group, along with intervention adherence measures and therapist training and certification procedures; (2) to test the efficacy of Strength at Home Couples Group for OEF/OIF/OND veterans by conducting a multiple site randomized trial comparing 10 sessions of Strength at Home Couples Group to 10 sessions of a supportive group therapy (ST) condition; and (3) to explore differences in compliance and process factors across conditions.

Being tested
Strength at Home Couples Group, Supportive Group Therapy
Keywords
Intimate partner aggression, Couples intervention, PTSD, Veterans, Prevention, Violence Prevention, Prevention of pertetration of intimate partner aggression.
Medical subject headings
Aggression, Stress Disorders, Post-Traumatic

What participants receive

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

  • Strength at Home Couples GroupBehavioural

    Also called PTSD-Focused Relationship Enhancement Therapy, Returning Veterans and Partners

    A multiple site randomized trial will compare 10 sessions of PF-RET to 10 sessions of a supportive group therapy. PF-RET focuses on 1) deployment stress and traumatic experiences impacting intimate relationships; 2) communication between intimate partners; 3) conflict and anger management; and 4) closeness and intimacy.

  • Supportive Group TherapyBehavioural

    Also called Psychological/Behavioral Placebo Control

    A general support group designed to enhance support for healthy relationship building.

Study groups in NCT00827879
Study groupRoleWhat they receive
Strength at Home Couples GroupExperimentalPTSD-Focused Cognitive Behavioral Therapy for Couples
Receives: Behavioral: Strength at Home Couples Group
Supportive Group TherapyPlacebo comparatorSupportive therapy for couples
Receives: Behavioral: Supportive Group Therapy

What is being measured

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

  1. Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews.

    Measured: Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment

Secondary outcomes (1)

  1. Evidence of change in risk factors (i.e. PTSD symptoms, anger, relationship satisfaction) implicated in the development of IPA assessed by questionnaires, clinical interviews, and psychophysiological measurements.

    Measured: Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment

Timeline

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

  1. First posted23 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionOct 2014
  4. Study completionOct 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00827879
Sponsor's protocol ID
U49CE001248
Status last verified
Jul 2017
First submitted
22 Jan 2009
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Norton, R. (1983). Measuring marital quality: A critical look at the dependent variable. Journal of Marriage and the Family, 45, 141-151.

  • Straus, M. A., Hamby, S. L., Boney-McCoy, S., & Sugarman, D. B. (1996). The Revised Conflict Tactics Scales (CTS2): Development and preliminary psychometric data. Journal of Family Issues,17, 283-316.

  • Spanier, G. B. (1976). Measuring dyadic adjustment: New scales for assessing the quality of marriage and similar dyads. Journal of Marriage and the Family, 38, 154-28.

  • Murphy CM, Hoover SA. Measuring emotional abuse in dating relationships as a multifactorial construct. Violence Vict. 1999 Spring;14(1):39-53.

    PubMed 10397625

  • Taft CT, Creech SK, Gallagher MW, Macdonald A, Murphy CM, Monson CM. Strength at Home Couples program to prevent military partner violence: A randomized controlled trial. J Consult Clin Psychol. 2016 Nov;84(11):935-945. doi: 10.1037/ccp0000129. Epub 2016 Sep 5.

    PubMed 27599224

Questions about this trial

What is this clinical trial studying?

A study testing Strength at Home Couples Group and Supportive Group Therapy in people with Aggression and Post Traumatic Stress Disorders, 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 6 inclusion and 9 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 12 Jul 2017. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (time frame: Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment). 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 NCT00827879, which also lists 5 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 12 Jul 2017.

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