PTSD
Conditions
Brief summary
The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.
Detailed description
The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.
Interventions
BEHAVIORALwritten exposure therapy
five sessions of writing about traumatic experience.
BEHAVIORALCPT, cognitive only
12 sessions of cognitive therapy related to traumatic experience.
Sponsors
University of Texas
United States Department of Defense
Boston VA Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD * Diagnosis of PTSD * Ability to speak, read and write English * Not currently engaged in psychosocial treatment for PTSD * Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.
Exclusion criteria
* Current suicide or homicide risk meriting crisis intervention * Active psychosis * Moderate to severe brain damage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale, 5 (CAPS-5) | Change from baseline to 10-, 20-, 30-weeks post first treatment session | The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Written Exposure Therapy 5 sessions of imaginal exposure therapy.
written exposure therapy: five sessions of writing about traumatic experience. | 85 |
| CPT, Cognitive Only 12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience. | 84 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | discontinued for medical reason or decision by study team | 9 | 16 |
| Overall Study | Withdrawal by Subject | 11 | 21 |
Baseline characteristics
| Characteristic | CPT, Cognitive Only | Total | Written Exposure Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 169 Participants | 85 Participants |
| Age, Continuous | 33.32 years STANDARD_DEVIATION 8.22 | 33.65 years STANDARD_DEVIATION 8.43 | 33.98 years STANDARD_DEVIATION 6.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 57 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 44 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 59 Participants | 33 Participants |
| Region of Enrollment United States | 84 Participants | 169 Participants | 85 Participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 67 Participants | 136 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 84 |
| other Total, other adverse events | 6 / 85 | 7 / 84 |
| serious Total, serious adverse events | 1 / 85 | 1 / 84 |
Outcome results
Primary
Clinician Administered PTSD Scale, 5 (CAPS-5)
The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.
Time frame: Change from baseline to 10-, 20-, 30-weeks post first treatment session
Population: Non-inferiority margin
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Written Exposure Therapy | Clinician Administered PTSD Scale, 5 (CAPS-5) | 10-week assessment | 31.55 score on a scale | Standard Error 1.13 |
| Written Exposure Therapy | Clinician Administered PTSD Scale, 5 (CAPS-5) | 20 week assessment | 29.59 score on a scale | Standard Error 1.45 |
| Written Exposure Therapy | Clinician Administered PTSD Scale, 5 (CAPS-5) | 30 week assessment | 27.77 score on a scale | Standard Error 1.61 |
| CPT, Cognitive Only | Clinician Administered PTSD Scale, 5 (CAPS-5) | 10-week assessment | 25.12 score on a scale | Standard Error 1.4 |
| CPT, Cognitive Only | Clinician Administered PTSD Scale, 5 (CAPS-5) | 20 week assessment | 25.41 score on a scale | Standard Error 1.49 |
| CPT, Cognitive Only | Clinician Administered PTSD Scale, 5 (CAPS-5) | 30 week assessment | 24.97 score on a scale | Standard Error 1.68 |