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

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ClinicalTrials.gov Identifier: NCT01022203
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : March 9, 2015
Last Update Posted : November 16, 2016
Sponsor:
Collaborator:
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stress Disorders, Post-Traumatic
Interventions Behavioral: Structured Approach Therapy
Other: PTSD Family Education
Enrollment 138
Recruitment Details  
Pre-assignment Details Twenty-four subjects (12 couples) were lost or withdrew from the study after providing consent and participating in the pretreatment assessment, but before randomization to one of the two treatment conditions (Structured Approach Therapy or PTSD Family Education).
Arm/Group Title Structured Approach Therapy PTSD Family Education
Hide Arm/Group Description

Couple's Therapy Intervention

Structured Approach Therapy: Couple's Therapy for PTSD

Educational Intervention.

PTSD Family Education: Education about PTSD for couples.

Period Title: PreTreatment Assessment
Started 58 56
Completed 58 56
Not Completed 0 0
Period Title: Post Treatment Assessment
Started 58 56
Completed 44 42
Not Completed 14 14
Reason Not Completed
Withdrawal by Subject             12             12
Physician Decision             2             0
Adverse Event             0             2
Period Title: Follow-Up Assessment
Started 44 42
Completed 42 40
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

Couple's Therapy Intervention

Structured Approach Therapy: Couple's Therapy for PTSD

Educational Intervention.

PTSD Family Education: Education about PTSD for couples.

Total of all reporting groups
Overall Number of Baseline Participants 58 56 114
Hide Baseline Analysis Population Description
These variables were entered into initial GLMM outcome models with no variable predicting outcome.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
 100.0%
56
 100.0%
114
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 56 participants 114 participants
Veterans Age 33.71  (7.01) 32.55  (6.16) 33.12  (6.56)
Partners Age 32.25  (7.89) 32.17  (7.68) 32.21  (7.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
Female
29
  50.0%
28
  50.0%
57
  50.0%
Male
29
  50.0%
28
  50.0%
57
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
Hispanic or Latino
2
   3.4%
0
   0.0%
2
   1.8%
Not Hispanic or Latino
56
  96.6%
56
 100.0%
112
  98.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 56 participants 114 participants
58 56 114
1.Primary Outcome
Title Psychological Functioning
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.
Arm/Group Title Structured Approach Therapy PTSD Family Education
Hide Arm/Group Description:
Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
Overall Number of Participants Analyzed 44 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Vet Pre-treatment Clinician Administered PTSD Scal 82.93  (3.31) 82.93  (3.31)
Vet Pre-treatment PTSD Checklist 60.84  (2.12) 60.81  (2.17)
Vet Post-treatment Clinician Administered PTSD 48.33  (3.71) 72.59  (3.79)
Vet Post-treatment PTSD Checklist 42.16  (2.38) 53.91  (2.48)
Vet Followup Clinician Administered PTSD Scale 44.64  (3.78) 71.93  (3.86)
Vet Followup PTSD Checklist 39.54  (2.48) 51.77  (2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Structured Approach Therapy, PTSD Family Education
Comments Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value .0001
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Relationship Functioning
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.
Arm/Group Title Structured Approach Therapy PTSD Family Education
Hide Arm/Group Description:
Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Overall Number of Participants Analyzed 44 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Vet Pre-Trtmt Dyadic Adjustment Scale 93.34  (3.53) 101.82  (3.60)
Vet Post-Trtmt Dyadic Adjustment Scale 105.18  (3.84) 101.77  (3.87)
Vet Followup Dyadic Adjustment Scale 106.76  (3.84) 101.95  (3.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Structured Approach Therapy, PTSD Family Education
Comments Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value .004
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Emotion Regulation
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.
Arm/Group Title Structured Approach Therapy PTSD Family Education
Hide Arm/Group Description:
Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Overall Number of Participants Analyzed 44 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Vet Pre-Trtmt Difficulties in Emotion Regulation 106.6  (23.9) 106.4  (22.4)
Vet Post-Trtmt Difficulties in Emotion Regulation 88.7  (24.4) 106.4  (22.4)
VetFollowup Difficulty in Emotion Regulation Scale 87.29  (26.84) 105.75  (25.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Structured Approach Therapy, PTSD Family Education
Comments General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Structured Approach Therapy (SAT) PTSD Family Education (PFE)
Hide Arm/Group Description

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

Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) 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.

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

PTSD Family Education (PFE): PTSD Family Education (PFE) 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.

All-Cause Mortality
Structured Approach Therapy (SAT) PTSD Family Education (PFE)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Structured Approach Therapy (SAT) PTSD Family Education (PFE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      0/56 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Structured Approach Therapy (SAT) PTSD Family Education (PFE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      2/56 (3.57%)    
Psychiatric disorders     
Domestic violence * 1 [1]  0/58 (0.00%)  0 2/56 (3.57%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Domestic violence.
[1]
Veteran and his spouse became intoxicated and veteran was violent with spouse. No serious injury and no medical treatment required. The spouse ended her relationship with the veteran.
The study's small sample size makes results preliminary and precludes formal hypothesis testing of mediating variables. Our report of decreased PTSD may reflect regression toward the mean.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frederic Sautter, Ph.D.
Organization: Southeast Louisiana Veterans Health Care System (SLVHCS)
Phone: 504-988-3026
EMail: Fsautter@tulane.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022203     History of Changes
Other Study ID Numbers: B6756-R
First Submitted: November 25, 2009
First Posted: December 1, 2009
Results First Submitted: December 12, 2014
Results First Posted: March 9, 2015
Last Update Posted: November 16, 2016