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

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ClinicalTrials.gov Identifier: NCT00827879
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Casey Taft, Boston VA Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE January 23, 2009
Last Update Posted Date July 12, 2017
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
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. [ Time Frame: Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strength at Home Couples Program (PTSD-Focused Relationship Enhancement Therapy for Returning Veterans)
Official Title  ICMJE Strength at Home Couples Program (Formerly: PTSD-Focused Relationship Enhancement Therapy for Returning Veterans and Their Partners)
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Aggression
  • Post Traumatic Stress Disorders
Intervention  ICMJE
  • 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
  • Behavioral: Supportive Group Therapy
    A general support group designed to enhance support for healthy relationship building.
    Other Name: Psychological/Behavioral Placebo Control
Study Arms  ICMJE
  • Experimental: Strength at Home Couples Group
    PTSD-Focused Cognitive Behavioral Therapy for Couples
    Intervention: Behavioral: Strength at Home Couples Group
  • Placebo Comparator: Supportive Group Therapy
    Supportive therapy for couples
    Intervention: Behavioral: Supportive Group Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
156
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2009)
440
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00827879
Other Study ID Numbers  ICMJE U49CE001248( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Casey Taft, Boston VA Research Institute, Inc.
Original Responsible Party Casey T. Taft, Ph.D., VA Boston Healthcare System
Current Study Sponsor  ICMJE Boston VA Research Institute, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Casey T Taft, Ph.D. National Center for PTSD, VA Boston Healthcare System
Principal Investigator: Suzannah Creech, PhD Providence VA Medical Center
PRS Account Boston VA Research Institute, Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP