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
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Sponsor:
Boston VA Research Institute, Inc.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Casey Taft, Boston VA Research Institute, Inc.
Tracking Information | |||||||
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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 |
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 |
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 |
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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
156 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |