PTSD
Conditions
Keywords
PTSD, OEF/OIF, Combat, Treatment, CPT, PCT, Cognitive
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALPresent 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* PTSD; * memory of the trauma; * able to read/write; * must be stable on medication for 3 months
Exclusion criteria
* Psychosis; * suicidal/homicidal intent; * alcohol/substance dependence; * no memory of the trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale | Post-treatment, at 3 months and 1 year | Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed. |
| PTSD Checklist (PCL) | post-treatment, at 3 months and 1 year | 17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory - II (BDI-II) | post-treatment, at 3 months and 1 year | Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed. |
| State-Trait Anger Scale (STAXI) | post-treatment, at 3 months and 1 year | Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37. |
| State-Trait Anxiety Scale | post-treatment, at 3 months and 1 year | Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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 | 36 |
| Total | 79 |
Baseline characteristics
| Characteristic | Cognitive Processing Therapy | Present Centered Therapy | Total |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 7.11 | 32.11 years STANDARD_DEVIATION 7.85 | 30.92 years STANDARD_DEVIATION 7.59 |
| Beck Depression Inventory | 27.70 units on a scale STANDARD_DEVIATION 9.68 | 28.22 units on a scale STANDARD_DEVIATION 10.21 | 27.94 units on a scale STANDARD_DEVIATION 9.86 |
| Clinician Administered PTSD Scale | 60.14 units on a scale STANDARD_DEVIATION 11.61 | 62.42 units on a scale STANDARD_DEVIATION 14.84 | 61.77 units on a scale STANDARD_DEVIATION 13.14 |
| PTSD Checklist | 53.83 units on a scale STANDARD_DEVIATION 9.87 | 53.49 units on a scale STANDARD_DEVIATION 9.33 | 53.65 units on a scale STANDARD_DEVIATION 9.52 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 43 Participants | 36 Participants | 79 Participants |
| State Trait Anger Expression Inventory | 28.14 units on a scale STANDARD_DEVIATION 5.52 | 26.35 units on a scale STANDARD_DEVIATION 6.07 | 27.16 units on a scale STANDARD_DEVIATION 5.86 |
| State Trait Anxiety | 43.19 units on a scale STANDARD_DEVIATION 5.6 | 43.14 units on a scale STANDARD_DEVIATION 4.18 | 43.17 units on a scale STANDARD_DEVIATION 4.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 36 |
| serious Total, serious adverse events | 1 / 43 | 0 / 36 |
Outcome results
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.
Time frame: Post-treatment, at 3 months and 1 year
Population: Generalized estimating equations (GEE) were used to test study hypotheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Processing Therapy | Clinician Administered PTSD Scale | post | 31.56 units on a scale | Standard Deviation 21.24 |
| Cognitive Processing Therapy | Clinician Administered PTSD Scale | 3-month | 31.65 units on a scale | Standard Deviation 21.77 |
| Cognitive Processing Therapy | Clinician Administered PTSD Scale | 12-month | 26.78 units on a scale | Standard Deviation 19.26 |
| Present Centered Therapy | Clinician Administered PTSD Scale | post | 42.62 units on a scale | Standard Deviation 23.76 |
| Present Centered Therapy | Clinician Administered PTSD Scale | 3-month | 38.73 units on a scale | Standard Deviation 18.38 |
| Present Centered Therapy | Clinician Administered PTSD Scale | 12-month | 32.12 units on a scale | Standard Deviation 22.48 |
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
Time frame: post-treatment, at 3 months and 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Processing Therapy | PTSD Checklist (PCL) | post | 33.48 units on a scale | Standard Deviation 15.75 |
| Cognitive Processing Therapy | PTSD Checklist (PCL) | 3-month | 35.55 units on a scale | Standard Deviation 14.17 |
| Cognitive Processing Therapy | PTSD Checklist (PCL) | 12-month | 33.72 units on a scale | Standard Deviation 13.69 |
| Present Centered Therapy | PTSD Checklist (PCL) | post | 42.88 units on a scale | Standard Deviation 23.76 |
| Present Centered Therapy | PTSD Checklist (PCL) | 3-month | 41.84 units on a scale | Standard Deviation 14.66 |
| Present Centered Therapy | PTSD Checklist (PCL) | 12-month | 34.88 units on a scale | Standard Deviation 12.32 |
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.
Time frame: post-treatment, at 3 months and 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Processing Therapy | Beck Depression Inventory - II (BDI-II) | post | 16.32 units on a scale | Standard Deviation 11.42 |
| Cognitive Processing Therapy | Beck Depression Inventory - II (BDI-II) | 3-month | 17.10 units on a scale | Standard Deviation 10.48 |
| Cognitive Processing Therapy | Beck Depression Inventory - II (BDI-II) | 12-month | 15.56 units on a scale | Standard Deviation 12.41 |
| Present Centered Therapy | Beck Depression Inventory - II (BDI-II) | post | 20.73 units on a scale | Standard Deviation 10.53 |
| Present Centered Therapy | Beck Depression Inventory - II (BDI-II) | 3-month | 18.95 units on a scale | Standard Deviation 9.67 |
| Present Centered Therapy | Beck Depression Inventory - II (BDI-II) | 12-month | 18.47 units on a scale | Standard Deviation 11.96 |
Secondary
State-Trait Anger Scale (STAXI)
Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.
Time frame: post-treatment, at 3 months and 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Processing Therapy | State-Trait Anger Scale (STAXI) | 12-month | 21.64 units on a scale | Standard Deviation 7.09 |
| Cognitive Processing Therapy | State-Trait Anger Scale (STAXI) | post | 21.75 units on a scale | Standard Deviation 5.58 |
| Cognitive Processing Therapy | State-Trait Anger Scale (STAXI) | 3-month | 21.26 units on a scale | Standard Deviation 6.49 |
| Present Centered Therapy | State-Trait Anger Scale (STAXI) | 12-month | 22.41 units on a scale | Standard Deviation 3.95 |
| Present Centered Therapy | State-Trait Anger Scale (STAXI) | post | 23.81 units on a scale | Standard Deviation 6.69 |
| Present Centered Therapy | State-Trait Anger Scale (STAXI) | 3-month | 23.09 units on a scale | Standard Deviation 5.04 |
Secondary
State-Trait Anxiety Scale
Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.
Time frame: post-treatment, at 3 months and 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Processing Therapy | State-Trait Anxiety Scale | post | 43.20 units on a scale | Standard Deviation 13.71 |
| Cognitive Processing Therapy | State-Trait Anxiety Scale | 3-month | 44.98 units on a scale | Standard Deviation 12.92 |
| Cognitive Processing Therapy | State-Trait Anxiety Scale | 12-month | 43.27 units on a scale | Standard Deviation 13.39 |
| Present Centered Therapy | State-Trait Anxiety Scale | post | 48.34 units on a scale | Standard Deviation 11.42 |
| Present Centered Therapy | State-Trait Anxiety Scale | 3-month | 47.21 units on a scale | Standard Deviation 13.2 |
| Present Centered Therapy | State-Trait Anxiety Scale | 12-month | 45.71 units on a scale | Standard Deviation 12.29 |