N/A
N=178
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT03962504 ↗Enrolled (actual)
178
Serious AEs
6.2%
Results posted
Jul 2024
Primary outcome: Primary: Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) — 26.17; 24.78 CAPS-5 total score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- trauma-focused treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) |
26.17; 24.78 | — |
| SECONDARY World Health Organization Quality of Life BREF |
3.21; 4.13 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03962504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.