An interventional study of Standard CPT and CPT-LEAP in Post Traumatic Stress Disorder, sponsored by Boston University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Boston University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants randomized to this arm will receive the adapted CPT-LEAP treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions).
Behavioral: CPT-LEAP
Participants randomized to this arm will receive standard CPT treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions).
Behavioral: Standard CPT
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.
Post traumatic stress disorder symptoms (PTSD)
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.
Time frame: immediately after treatment, 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Boston University