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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)Experimental treatment 1 intervention
Group B: Standard Cognitive Therapy Processing (CPT)Active comparator 1 intervention

Trial outcomes

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.

Time frame
immediately after treatment, 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Boston University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: