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| Name | Class |
|---|---|
| Southeast Louisiana Veterans Health Care System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Approach Therapy | Experimental | Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD. |
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| PTSD Family Education | Active Comparator | Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Approach Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic J Sautter, PhD | Southeast Louisiana Veterans Health Care System, New Orleans, LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Louisiana Veterans Health Care System, New Orleans, LA | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26213789 | Result | 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. | |
| 27472747 | Result | 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. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Structured Approach Therapy | Couple's Therapy Intervention Structured Approach Therapy: Couple's Therapy for PTSD |
| FG001 | PTSD Family Education | Educational Intervention. PTSD Family Education: Education about PTSD for couples. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PreTreatment Assessment |
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| Post Treatment Assessment |
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| Follow-Up Assessment |
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These variables were entered into initial GLMM outcome models with no variable predicting outcome.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Couple's Therapy Intervention Structured Approach Therapy: Couple's Therapy for PTSD |
| BG001 | Arm 2 | Educational Intervention. PTSD Family Education: Education about PTSD for couples. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education. | Posted | Mean | Standard Deviation | units on a scale | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Structured Approach Therapy (SAT) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Domestic violence | Psychiatric disorders | Domestic violence. | Non-systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederic Sautter, Ph.D. | Southeast Louisiana Veterans Health Care System (SLVHCS) | 504-988-3026 | Fsautter@tulane.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| PTSD Family Education | Other | 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. |
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| 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). |
| Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | PTSD Family Education | 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. |
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| Secondary | 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. | Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education. | Posted | Mean | Standard Deviation | units on a scale | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
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| Secondary | 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). | Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education. | Posted | Mean | Standard Deviation | units on a scale | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). |
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| 58 |
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| EG001 | PTSD Family Education (PFE) | 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. | 0 | 56 | 2 | 56 |
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| Vet Followup Dyadic Adjustment Scale |
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| VetFollowup Difficulty in Emotion Regulation Scale |
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