Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard CPT, CPT-LEAP.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- 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. - Behavioral CPT-LEAP
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.
Primary outcome measures
- Post traumatic stress disorder symptoms (PTSD) [Time frame: immediately after treatment, 3 months]
Eligibility criteria
Inclusion criteria
- Current diagnosis of PTSD
- Self-identification as a sexual or gender minority (SGM) individual
- Endorsement of SGM stress experiences with moderate distress
- For patients who take psychiatric medication, stable dose one month prior to enrollment
- Reside in Massachusetts.
Exclusion criteria
- Current active suicidal or homicidal ideation with intent or plan
- Unstable bipolar disorder/current mania
- Unstable psychotic disorder/current psychosis
- Current severe substance use that warrants immediate medical attention
- Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures
- Past completion of CPT or current trauma-focused treatment
- Unwillingness to consent to audio or video recording of assessment and treatment sessions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Boston Healthcare System — Jamaica Plain
Identifiers
NCT: NCT07714083 · H-45022 · 1K23MH133986-01A1