Panic Attacks, PTSD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMultiple Channel Exposure Therapy - Veterans
MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.
BEHAVIORALCognitive Processing Therapy
CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
Intervention model description
Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* being a Veteran of any era; * being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD; * being stable on psychotropic medication for 4 weeks before study participation; and * being at least 18 years of age.
Exclusion criteria
* active substance dependence, or bipolar or psychotic disorders; * severe depression and \[active suicidal ideation and intent\] (based on ADIS-IV & BDI-II); * cognitive impairment as indicated by the SLUMS; and * Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Baseline, 1-week post-treatment and 3-month follow-up | 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. |
| Change in PDSS Scores Over Time for MCET-V and CPT Groups | Baseline, 1-week post, and 3-month follow-up | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 32 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up (3 Month) | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Multiple Channel Exposure Therapy (MCET-V) | Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 29 Participants | 62 Participants |
| Age, Continuous | 42.61 years STANDARD_DEVIATION 13.7 | 41.56 years STANDARD_DEVIATION 13.26 | 42.12 years STANDARD_DEVIATION 13.4 |
| Race/Ethnicity, Customized African American | 10 Participants | 13 Participants | 23 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Latino | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 29 Participants | 25 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 32 |
| serious Total, serious adverse events | 0 / 36 | 0 / 32 |
Outcome results
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.
Time frame: Baseline, 1-week post, and 3-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multiple Channel Exposure Therapy (MCET-V) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | Baseline | 18.5 units on a scale | Standard Deviation 3.84 |
| Multiple Channel Exposure Therapy (MCET-V) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | 1-week post | 12.81 units on a scale | Standard Deviation 6.33 |
| Multiple Channel Exposure Therapy (MCET-V) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | 3-month follow up | 10.93 units on a scale | Standard Deviation 7.53 |
| Cognitive Processing Therapy (CPT) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | Baseline | 16.28 units on a scale | Standard Deviation 4.57 |
| Cognitive Processing Therapy (CPT) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | 1-week post | 10.20 units on a scale | Standard Deviation 5.75 |
| Cognitive Processing Therapy (CPT) | Change in PDSS Scores Over Time for MCET-V and CPT Groups | 3-month follow up | 10.62 units on a scale | Standard Deviation 6.51 |
Comparison: Longitudinal analysis of PDSS scoresp-value: 0.68Mixed Models Analysis
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.
Time frame: Baseline, 1-week post-treatment and 3-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multiple Channel Exposure Therapy (MCET-V) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Pre-Treatment | 81.8 units on a scale | Standard Deviation 21 |
| Multiple Channel Exposure Therapy (MCET-V) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Post-Treatment (1 week) | 67.8 units on a scale | Standard Deviation 24.2 |
| Multiple Channel Exposure Therapy (MCET-V) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Follow-Up (3 months) | 66.6 units on a scale | Standard Deviation 20.4 |
| Cognitive Processing Therapy (CPT) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Pre-Treatment | 80.5 units on a scale | Standard Deviation 19.9 |
| Cognitive Processing Therapy (CPT) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Post-Treatment (1 week) | 68.1 units on a scale | Standard Deviation 26.4 |
| Cognitive Processing Therapy (CPT) | Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups | Follow-Up (3 months) | 66.2 units on a scale | Standard Deviation 28 |
p-value: 0.3Fisher Exact