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

This study has been completed.

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by (Responsible Party):

Casey Taft, Boston VA Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT00827879

First received: January 22, 2009

Last updated: July 11, 2017

Last verified: July 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

January 22, 2009

Last Updated Date

July 11, 2017

Start Date ^ICMJE

February 2009

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

Complete list of historical versions of study NCT00827879 on ClinicalTrials.gov Archive Site

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 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 Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Enrollment ^ICMJE

156

Completion Date

October 2014

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

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