Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress
Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cara Herbitter, PhD, MPH
- Phone Number: 857-364-6528
- Email: Cara.Herbitter@va.gov
Study Locations
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Massachusetts
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Jamaica Plain, Massachusetts, United States, 02130
- VA Boston Healthcare System
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Contact:
- Cara Herbitter, PhD, MPH
- Phone Number: 857-364-6528
- Email: Cara.Herbitter@va.gov
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)
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).
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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.
|
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Active Comparator: Standard Cognitive Therapy Processing (CPT)
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post traumatic stress disorder symptoms (PTSD)
Time Frame: immediately after treatment, 3 months
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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.
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immediately after treatment, 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cara Herbitter, PhD, MPH, Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-45022
- 1K23MH133986-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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