Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress

NCT07714083 | Not Yet Recruiting

• 2 other identifiers: H-450221K23MH133986-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Cognitive Processing Therapy (CPT); Lived experience stress; Lived Experience Adapted Protocol (LEAP); Veterans

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately after treatment, 3 months

Study Arms (2)

Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)

EXPERIMENTAL

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

Standard Cognitive Therapy Processing (CPT)

ACTIVE COMPARATOR

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

Interventions

CPT-LEAP BEHAVIORAL

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.

Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)

Standard CPT BEHAVIORAL

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.

Standard Cognitive Therapy Processing (CPT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as a sexual or gender minority.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VA Boston Healthcare System

Jamaica Plain, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Cara Herbitter, PhD, MPH

  Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Herbitter, PhD, MPH

CONTACT

857-364-6528; Cara.Herbitter@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)