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

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	Complete list of historical versions of study NCT00827879 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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 *	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.; 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. Epub 2016 Sep 5.
* 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	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	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Casey Taft, Boston VA Research Institute, Inc.
Study Sponsor ICMJE	Boston VA Research Institute, Inc.
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