National Center for PTSD at VA Boston Healthcare System
Boston, Massachusetts, 02130, United States
NCT Number: NCT01800773
Although evidence-based treatments for PTSD exist, a significant minority of individuals do not benefit from these treatments and many individuals to not seek treatment, citing barriers such as time commitment and expense of treatment. The goal of the proposed study is to establish an alternative PTSD treatment that is efficacious and efficient.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02130, United States
Prior research has demonstrated that written exposure therapy (WET), is an efficient, well-tolerated, and efficacious treatment for PTSD. The proposed project takes the next step in establishing WET as an intervention for PTSD by examining whether WET is equally efficacious to an evidence-based treatment for PTSD. Using a randomized noninferiority controlled trial, 126 adults diagnosed with PTSD will be assigned to either WET or Cognitive Processing Therapy (CPT). Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD participants assigned to WET demonstrate PTSD symptom severity outcome that is noninferior to PTSD participants assigned to CPT. Secondary aims include examining whether expected treatment gains are sustained for both treatments and whether WET has a lower treatment dropout rate relative to CPT. Exploratory aims include examining moderators and mediators of WET and CPT. If the hypothesis that WET is noninferior to CPT is confirmed then a brief treatment option for PTSD will be established.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.
Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.
Time frame: change from baseline PTSD symptom severity at 36 weeks post first treatment session
Total score on the CAPS will be used to assess change in PTSD symptom severity from baseline (pre-treatment) until 36- weeks post first treatment session.
Time frame: course of treatment
Treatment condition differences in treatment drop out rate at post-treatment (treatment duration is 5 weeks for WET condition and 12 weeks for CPT condition).
Boston University
Other
Written Exposure Therapy for Post Traumatic Stress Disorder: A Randomized Noninferiority Trial
Acronym: WET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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