PTSD
Conditions
Keywords
PTSD, psychosocial treatment, cognitive behavioral treatment, veterans, quality of life
Brief summary
The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.
Detailed description
Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.
Interventions
BEHAVIORALtrauma-focused treatment
cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be unaware of participant conditions. Assessors will not have access to any study materials in which unmasking could occur. Participants will be instructed to not reveal their treatment condition to the assessors.
Intervention model description
The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran status * Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5) * If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry
Exclusion criteria
* Current engagement psychosocial treatment for PTSD * Current diagnosis of substance dependence * abuse will not be excluded; determined with severe combined immunodeficiency (SCID) * Current psychosis or unstable bipolar disorder diagnosis * determined with the Mini International Neuropsychiatric Interview (MINI)clinician-administered interview * High suicidal risk * i.e., intent with a plan; assessed with the MINI suicide module * Significant cognitive impairment (assessed with the Montreal Cognitive Assessment \[MoCA\] and clinical judgment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) | change score baseline to 20 weeks | The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life BREF | change score baseline to 20 weeks | The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Written Exposure Therapy The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. | 88 |
| Prolonged Exposure Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. | 90 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 11 | 32 |
Baseline characteristics
| Characteristic | Written Exposure Therapy | Total | Prolonged Exposure |
|---|---|---|---|
| Age, Continuous | 46.17 years STANDARD_DEVIATION 13.33 | 44.97 years STANDARD_DEVIATION 13.67 | 43.79 years STANDARD_DEVIATION 13.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 34 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) White | 55 Participants | 109 Participants | 54 Participants |
| Region of Enrollment United States | 88 Participants | 178 Participants | 90 Participants |
| Sex: Female, Male Female | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Male | 67 Participants | 134 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 90 |
| other Total, other adverse events | 6 / 88 | 5 / 90 |
| serious Total, serious adverse events | 4 / 88 | 7 / 90 |
Outcome results
Primary
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)
The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity.
Time frame: change score baseline to 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Written Exposure Therapy | Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) | 26.17 CAPS-5 total score |
| Prolonged Exposure | Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) | 24.78 CAPS-5 total score |
Secondary
World Health Organization Quality of Life BREF
The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life.
Time frame: change score baseline to 20 weeks
Population: The sample size is substantially less than the number randomized because the self-report measure was mailed to the study team due to COVID-19 pandemic and response rate for self-report measures was much lower than clinician-administered interviews (i.e., CAPS-5). Accordingly, the planned analysis is not conducted as it is underpowered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Written Exposure Therapy | World Health Organization Quality of Life BREF | 3.21 change score; score on a scale | Standard Deviation 0.49 |
| Prolonged Exposure | World Health Organization Quality of Life BREF | 4.13 change score; score on a scale | Standard Deviation 1.15 |