Recruiting

Cognitive Processing Therapy

Sponsor:

Palo Alto University

Code:

NCT04230668

Conditions

Posttraumatic Stress Disorder

Borderline Personality Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy with Suicide Risk Management

Treatment as Usual with Suicide Rick Management

Study Details

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 ID

NCT04230668

Start date

Oct 1, 2022

Status verified date

Jan, 2024

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
  • Borderline Symptom List 23 (BSL-23) [SELF-REPORT] [ Time Frame: Baseline, once a week while in treatment (for 6 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Palo Alto University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ariana Guenther, B.A. (Hons)

650-485-1513bestlab@paloaltou.edu

More Information

Sponsor

Palo Alto University

Last update posted

Jan 17, 2024

Last verified

Jan, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto University on 2024-01-17.