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Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Approach Therapy
PTSD Family Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Couples Therapy, PTSD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Exposure to at least one combat-related stressful event during combat deployment,
  • Current diagnostic 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 recent physical assault/abuse,
  • Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy)
  • Currently receiving couples therapy or family therapy

Sites / Locations

  • Southeast Louisiana Veterans Health Care System, New Orleans, LA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured Approach Therapy

PTSD Family Education

Arm Description

Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.

Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.

Outcomes

Primary Outcome Measures

Psychological Functioning
Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).

Secondary Outcome Measures

Relationship Functioning
Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.
Emotion Regulation
Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).

Full Information

First Posted
November 25, 2009
Last Updated
October 5, 2016
Sponsor
VA Office of Research and Development
Collaborators
Southeast Louisiana Veterans Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01022203
Brief Title
Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Official Title
Couples Treatment of PTSD in OEF/OIF Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Southeast Louisiana Veterans Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Couples Therapy, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Approach Therapy
Arm Type
Experimental
Arm Description
Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
Arm Title
PTSD Family Education
Arm Type
Active Comparator
Arm Description
Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.
Intervention Type
Behavioral
Intervention Name(s)
Structured Approach Therapy
Intervention Description
The Structured Approach Therapy intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach Veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication.
Intervention Type
Other
Intervention Name(s)
PTSD Family Education
Intervention Description
The PTSD Family Education intervention provides education for Veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included.
Primary Outcome Measure Information:
Title
Psychological Functioning
Description
Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).
Time Frame
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Secondary Outcome Measure Information:
Title
Relationship Functioning
Description
Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.
Time Frame
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Title
Emotion Regulation
Description
Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).
Time Frame
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exposure to at least one combat-related stressful event during combat deployment, Current diagnostic 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 recent physical assault/abuse, Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy) Currently receiving couples therapy or family therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic J Sautter, PhD
Organizational Affiliation
Southeast Louisiana Veterans Health Care System, New Orleans, LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Louisiana Veterans Health Care System, New Orleans, LA
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26213789
Citation
Sautter FJ, Glynn SM, Cretu JB, Senturk D, Vaught AS. Efficacy of structured approach therapy in reducing PTSD in returning veterans: A randomized clinical trial. Psychol Serv. 2015 Aug;12(3):199-212. doi: 10.1037/ser0000032.
Results Reference
result
PubMed Identifier
27472747
Citation
Sautter FJ, Glynn SM, Becker-Cretu JJ, Senturk D, Armelie AP, Wielt DB. Structured Approach Therapy for Combat-Related PTSD in Returning U.S. Veterans: Complementary Mediation by Changes in Emotion Functioning. J Trauma Stress. 2016 Aug;29(4):384-7. doi: 10.1002/jts.22120. Epub 2016 Jul 29.
Results Reference
result

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Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education

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