RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD

Quick Facts

Study Start:2022-10-01
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04230668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-65 years
  2. * Must reside in the Bay Area, CA
  3. * Current DSM-5 diagnosis of PTSD and BPD
  4. * Must be willing to be audio- or videorecorded for assessment and treatment sessions
  1. * Acute mania, acute psychosis, or intellectual disability
  2. * Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
  3. * Severe impairments in written and aural comprehension
  4. * EU individuals

Contacts and Locations

Study Contact

Ariana Guenther, B.A.
CONTACT
650-485-1513
bestlab@paloaltou.edu

Principal Investigator

Janice R Kuo, PhD
PRINCIPAL_INVESTIGATOR
Palo Alto University

Study Locations (Sites)

Palo Alto University
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Palo Alto University

  • Janice R Kuo, PhD, PRINCIPAL_INVESTIGATOR, Palo Alto University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Processing Therapy
  • Suicide Risk Management
  • Suicide
  • Self-harm

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder
  • Borderline Personality Disorder