Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PTSD Couples Therapy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: November 25, 2009
Last updated: October 7, 2014
Last verified: October 2014

The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD, called Structured Approach Therapy, to decrease PTSD and improve the marital and social functioning of OIF/OEF veterans. The effectiveness of couples therapy will be compared with the effectiveness of an educational intervention.

Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Structured Approach Therapy
Behavioral: PTSD Family Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Couples Treatment of PTSD in OEF/OIF Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychological functioning [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marital Functioning [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ] [ Designated as safety issue: No ]
  • Emotion Regulation [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Couple's Therapy Intervention
Behavioral: Structured Approach Therapy
Couple's Therapy for PTSD
Active Comparator: Arm 2
Educational Intervention.
Behavioral: PTSD Family Education
Education about PTSD for couples.

Detailed Description:

The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy (SAT), by randomly assigning 60 OEF/OIF veterans and their partners to either a 12-15 session SAT program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two treatment conditions will be ascertained by obtaining measures of PTSD severity, relationship functioning, and emotion regulation prior to treatment, immediately after treatment, and three months after the last treatment session. We will test the hypothesis that couples participating in SAT will show significantly greater improvements on measures from all three outcome domains. These hypotheses will be tested by using mixed effects repeated measures analyses to compare mean scale scores from the respective outcome measures across the two treatment groups (SAT, Education), over successive time periods (pre-test, post-test, 12 week follow- up. The objectives of the intervention are to decrease PTSD severity, improve relationship and family functioning, and decrease problems in emotion regulation, in a group of young veterans at risk for developing chronic PTSD, and to reduce emotional distress and relationship and family problems in their spouses.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Exposure to at least one combat-related Criterion A stressful event during OEF/OIF deployment,
  • Current DSM-IVR criteria for PTSD for that event, and
  • Veteran is in a committed relationship and living with an opposite sex partner for at least six months.

Exclusion Criteria:

  • Current psychotic symptoms in either partner,
  • Current diagnosis of alcohol or drug dependence in either partner,
  • History of recurrent physical assault/abuse as indicated by responses to the Conflict Tactics Scale,
  • Currently receiving an evidence-based PTSD treatment (exposure-based therapy, CBT), and
  • Currently receiving couples therapy or family therapy
  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 identifier: NCT01022203

United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Principal Investigator: Frederick Sautter, PhD Southeast Veterans Healthcare System, New Orleans
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT01022203     History of Changes
Other Study ID Numbers: B6756-R
Study First Received: November 25, 2009
Last Updated: October 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Couples Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Stress Disorders, Traumatic processed this record on February 27, 2015