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The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.
The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.
CPT has been shown to be effective in treating trauma survivors in several treatment outcome studies, but utility with Veterans has only been examined with male Veterans in one small pilot study. In addition CPT has never been compared to a treatment as usual or supportive psychotherapy condition to control for the specific and nonspecific elements of treatment. Although Cognitive Processing Therapy is one of the main treatment modalities at several VA's, including Cincinnati, it has never been compared to PCT, nor has it been used in a large, randomized study of male OEF/OIF Veterans. It is hypothesized that individual receiving CPT will show a larger reduction in posttraumatic stress disorder and related symptoms than those individuals receiving PCT.
All male OEF/OIF Veterans will be screened for their appropriateness for the study by phone screen and then by an assessment technician. The Veteran will be assessed at pre, post, 3-month, and 1-year follow-up. The assessment technicians will be blind to the participant's condition. CPT is a 12 week long individual psychotherapy treatment shown to be effective at reducing PTSD and related symptoms for survivors of various types of traumas, including combat. PCT is a supportive counseling treatment that has been utilized as an alternative to waitlist control in VA cooperative studies of PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy | Active Comparator | Cognitive Processing Therapy |
|
| Present Centered Therapy | Active Comparator | Present Centered Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale | Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed. | Post-treatment, at 3 months and 1 year |
| PTSD Checklist (PCL) | 17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed | post-treatment, at 3 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory - II (BDI-II) | Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed. | post-treatment, at 3 months and 1 year |
| State-Trait Anger Scale (STAXI) |
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Inclusion Criteria:
Exclusion Criteria:
Must be a male combat Veteran
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Chard, PhD | Cincinnati VA Medical Center, Cincinnati, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Processing Therapy | Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others. |
| FG001 | Present Centered Therapy | Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Processing Therapy | Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clinician Administered PTSD Scale | Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed. | Generalized estimating equations (GEE) were used to test study hypotheses. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment, at 3 months and 1 year |
|
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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 | Cognitive Processing Therapy | Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self Harm | Psychiatric disorders | Systematic Assessment | Pt had a fight with mother over his recent relapse to substances. Pt was admitted for passive self-harm thoughts. Pt completed 8 sessions of therapy with a significant reduction in PTSD symptoms. The event was found to be unrelated by the IRB. |
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Significant amounts of missing data from patients not attending assessment. Drop out rate from treatment was higher than other clinical trials of CPT and PCT in civilian samples, but in keeping with other studies of Veterans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen M. Chard | Cincinnati VA Medical Center | 859-572-6741 | Kathleen.Chard@va.gov |
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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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|
| Present Centered Therapy | Behavioral | Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors |
|
Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.
| post-treatment, at 3 months and 1 year |
| State-Trait Anxiety Scale | Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73. | post-treatment, at 3 months and 1 year |
| Present Centered Therapy |
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Clinician Administered PTSD Scale | Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist | 17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory | Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed. | Mean | Standard Deviation | units on a scale |
|
| State Trait Anxiety | Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37. | Mean | Standard Deviation | units on a scale |
|
| State Trait Anger Expression Inventory | Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73. | Mean | Standard Deviation | units on a scale |
|
Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors |
|
|
| Primary | PTSD Checklist (PCL) | 17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed | Posted | Mean | Standard Deviation | units on a scale | post-treatment, at 3 months and 1 year |
|
|
|
| Secondary | Beck Depression Inventory - II (BDI-II) | Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed. | Posted | Mean | Standard Deviation | units on a scale | post-treatment, at 3 months and 1 year |
|
|
|
| Secondary | State-Trait Anger Scale (STAXI) | Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37. | Posted | Mean | Standard Deviation | units on a scale | post-treatment, at 3 months and 1 year |
|
|
|
| Secondary | State-Trait Anxiety Scale | Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73. | Posted | Mean | Standard Deviation | units on a scale | post-treatment, at 3 months and 1 year |
|
|
|
| 1 |
| 43 |
| 0 |
| 43 |
| EG001 | Present Centered Therapy | Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors | 0 | 36 | 0 | 36 |
|
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| 12-month |
|
| 12-month |
|
| 12-month |
|
| 12-month |
|