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NCT Number: NCT07714083

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System

Jamaica Plain, Massachusetts, 02130, United States

Location contact

Cara Herbitter, PhD, MPH

CONTACT

[email protected]

857-364-6528

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Post traumatic stress disorder symptoms (PTSD)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cara Herbitter, PhD, MPH

CONTACT

[email protected]

857-364-6528

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

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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