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 posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase of the study will examine the feasibility and acceptability of MCET-V.
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 first phase of the study is to evaluate the feasibility and acceptability of the multi-component cognitive-behavioral treatment in an open trial.
Interventions
BEHAVIORALMultiple Channel Exposure Therapy- Veterans
Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* being a veteran of any era; * being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans Affairs Medical Center (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 Structured Clinical Interview for DSM-IV disorders \[SCID-IV\] & Beck Depression Inventory-2nd edition \[BDI-II\]); * cognitive impairment as indicated by the St. Louis University Mental Status exam (SLUMS); and * veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | 1-week post-treatment (approximately week 14) | The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) | 3 Months | The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multiple Channel Exposure Therapy (MCET) 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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Multiple Channel Exposure Therapy (MCET) |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 6.9 |
| Beck Anxiety Inventory | 40.6 units on a scale STANDARD_DEVIATION 9.93 |
| Beck Depression Inventory | 36.4 units on a scale STANDARD_DEVIATION 8.11 |
| Gender Female | 4 Participants |
| Gender Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Clinician Administered PTSD Scale (CAPS)
The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.
Time frame: 1-week post-treatment (approximately week 14)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCET-V | Clinician Administered PTSD Scale (CAPS) | 29.5 units on a scale | Standard Deviation 23.3 |
Primary
Clinician Administered PTSD Scale (CAPS)
The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.
Time frame: 3-month follow-up (approximately week 26)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCET-V | Clinician Administered PTSD Scale (CAPS) | 17 units on a scale | Standard Deviation 1.41 |
Secondary
Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)
The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.
Time frame: 3 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCET-V | Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) | Participants without panic disorder | 100 percentage of participants |
| MCET-V | Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) | Participants with panic disorder | 0 percentage of participants |