VA Boston Healthcare System
Jamaica Plain, Massachusetts, 02130, United States
NCT Number: NCT07714083
Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.
The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Jamaica Plain, Massachusetts, 02130, United States
This study will occur in two phases.
Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).
Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session.
CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.
Time frame: immediately after treatment, 3 months
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5). The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Contact information is provided by the study sponsor or research team.
Boston University
Other
Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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