Clinical Trials Logo

Clinical Trial Summary

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 Iraqi war Veterans and their partners. The effectiveness of couples therapy will be compared with the effectiveness of a couple-based educational intervention.


Clinical Trial Description

The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy, by randomly assigning 57 Iraqi war Veterans and their partners to either a 12-15 session Structured Approach Therapy program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two experimental conditions will be ascertained by obtaining measures of PTSD severity from Veterans and measures of relationship functioning and emotion regulation from Veterans and their partners prior to treatment, immediately after treatment, and three months after the last treatment session. The investigators will test the hypothesis that couples participating in Structured Approach Therapy will show significantly greater improvements on all three clinical outcome measures than couples participating in PTSD Family Education. These hypotheses will be tested with an intent-to-treat analysis using general linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcome, separately for the Veterans and their partners. The objectives of the Structured Approach Therapy 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 partners. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01022203
Study type Interventional
Source VA Office of Research and Development
Contact
Status Active, not recruiting
Phase N/A
Start date August 2010
Completion date May 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05620381 - Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Completed NCT02856412 - Improving Mind/Body Health and Functioning With Integrative Exercise N/A
Recruiting NCT05400200 - PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management N/A
Not yet recruiting NCT06088303 - Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication N/A
Not yet recruiting NCT03652922 - Propranolol Reactivation Mismatch (PRM) Treatment for PTSD Phase 4
Completed NCT02875912 - Prospective Evaluation of Family Care Rituals in the ICU N/A
Completed NCT01589575 - Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives N/A
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT01291368 - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care N/A
Active, not recruiting NCT00657787 - Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
Completed NCT00835627 - Treatment Trial for Psychogenic Nonepileptic Seizures Phase 4
Completed NCT01365247 - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00880152 - Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study N/A
Completed NCT00419029 - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment N/A
Completed NCT00514956 - Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT00333710 - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD N/A
Completed NCT01120847 - Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Completed NCT00069225 - Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder N/A
Completed NCT00055354 - Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00186212 - Alternative Support for Rural and Isolated Women in an HMO Phase 3