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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Boston VA Research Institute, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Casey Taft, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00827879
First received: January 22, 2009
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Aggression
Post Traumatic Stress Disorders
Behavioral: Strength at Home Couples Group
Behavioral: Supportive Group Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Strength at Home Couples Program (Formerly: PTSD-Focused Relationship Enhancement Therapy for Returning Veterans and Their Partners)

Resource links provided by NLM:


Further study details as provided by Boston VA Research Institute, Inc.:

Primary Outcome Measures:
  • Evidence of reduced incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. [ Time Frame: Pre- and post treatment, 6 months and 12 months following treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of decreased risk factors (i.e. PTSD symptoms, anger, relationship satisfaction) implicated in the development of IPA assessed by questionnaires, clinical interviews, and psychophysiological measurements. [ Time Frame: Pre and post treatment, 6 and 12 months following treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: February 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength at Home Couples Group Behavioral: Strength at Home Couples Group
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.
Other Names:
  • PTSD-Focused Relationship Enhancement Therapy
  • Returning Veterans and Partners
Placebo Comparator: Supportive Group Therapy Behavioral: Supportive Group Therapy
A general support group designed to enhance support for healthy relationship building.
Other Name: Psychological/Behavioral Placebo Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827879

Contacts
Contact: Jamie M Howard, Ph.D. 857-364-4648 Jamie.Howard3@va.gov

Locations
United States, Massachusetts
National Center for PTSD, VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Jamie M Howard, Ph.D.    857-364-4648    Jamie.Howard3@va.gov   
Principal Investigator: Casey T Taft, PH. D.         
United States, Rhode Island
Providence VA Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: Suzannah E Creech, PhD    401-273-7100 ext 3076    Suzannah.Creech@va.gov   
Principal Investigator: Tracie Shea, PhD         
Sponsors and Collaborators
Boston VA Research Institute, Inc.
Investigators
Principal Investigator: Casey T Taft, Ph.D. National Center for PTSD, VA Boston Healthcare System
Principal Investigator: Tracie Shea, PhD Providence VA Medical Center
  More Information

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.

Responsible Party: Casey Taft, Principal Investigator, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00827879     History of Changes
Other Study ID Numbers: U49/CE001248
Study First Received: January 22, 2009
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Boston VA Research Institute, Inc.:
Intimate partner aggression
Couples intervention
PTSD
Veterans
Prevention
Violence Prevention
Prevention of pertetration of intimate partner aggression.

Additional relevant MeSH terms:
Aggression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014