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To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.
With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The purpose of the study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCET-V | Experimental | Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously. |
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| CPT | Active Comparator | Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Channel Exposure Therapy - Veterans | Behavioral | MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity. | Baseline, 1-week post-treatment and 3-month follow-up |
| Change in PDSS Scores Over Time for MCET-V and CPT Groups | The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity. | Baseline, 1-week post, and 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Teng, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
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A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Channel Exposure Therapy (MCET-V) | MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously. |
| FG001 | Cognitive Processing Therapy (CPT) | CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
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| Post-Treatment (1 Week) |
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| Follow-Up (3 Month) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiple Channel Exposure Therapy (MCET-V) | MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously. |
| BG001 | Cognitive Processing Therapy (CPT) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1-week post-treatment and 3-month follow-up |
|
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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 | Multiple Channel Exposure Therapy -Veterans (MCET-V) | MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy-Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Teng | Michael E. DeBakey VA Medical Center | (713) 578-5513 | Ellen.Teng@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
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Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
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Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
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| Cognitive Processing Therapy | Behavioral | CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms. |
| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Change in PDSS Scores Over Time for MCET-V and CPT Groups | The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1-week post, and 3-month follow-up |
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| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Cognitive Processing Therapy (CPT) | CPT is a cognitive-behavioral treatment for persons with PTSD Cognitive-Processing Therapy: Participants will be randomly assigned to receive either MCET-V or cognitive processing therapy (CPT), a standard PTSD treatment. Patients in both the MCET-V and CPT conditions will receive 12, 90-minute sessions of individual therapy twice a week over a 6-week period. | 0 | 32 | 0 | 32 |
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| 3-month follow up |
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