Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

Palo Alto University

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Borderline Personality Disorder

Treatments: Behavioral: Cognitive Processing Therapy with Suicide Risk Management; Behavioral: Treatment as Usual with Suicide Rick Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04230668

CPT for PTSD-BPD

1R34MH124968-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-65 years
• Must reside in the Bay Area, CA
• Current DSM-5 diagnosis of PTSD and BPD
• Must be willing to be audio- or videorecorded for assessment and treatment sessions

Exclusion criteria

• Acute mania, acute psychosis, or intellectual disability
• Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
• Severe impairments in written and aural comprehension
• EU individuals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

CPT + SRM

Experimental group

Description:

Participants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions.

Treatment:

Behavioral: Cognitive Processing Therapy with Suicide Risk Management

TAU + SRM

Experimental group

Description:

Participants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions.

Treatment:

Behavioral: Treatment as Usual with Suicide Rick Management