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

NCT ID: NCT04230668

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-01-31

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPT + SRM

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.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy with Suicide Risk Management

Intervention Type: BEHAVIORAL

CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.

TAU + SRM

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.

Group Type: EXPERIMENTAL

Treatment as Usual with Suicide Rick Management

Intervention Type: BEHAVIORAL

In the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes.

Interventions

Cognitive Processing Therapy with Suicide Risk Management

CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.

Intervention Type: BEHAVIORAL

Treatment as Usual with Suicide Rick Management

In the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toronto Metropolitan University

OTHER

Sponsor Role: collaborator

York University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Palo Alto University

OTHER

Sponsor Role: lead

Responsible Party

Janice Kuo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice R Kuo, PhD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto University

Locations

Palo Alto University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ariana Guenther, B.A.

Role: CONTACT

bestlab@paloaltou.edu

650-485-1513

Facility Contacts

Ariana Guenther, B.A. (Hons)

Role: primary

bestlab@paloaltou.edu

650-485-1513

References

Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.

Reference Type: BACKGROUND

Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.

Reference Type: BACKGROUND

Other Identifiers

1R34MH124968-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CPT for PTSD-BPD

Identifier Type: -

Identifier Source: org_study_id