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

NCT04230668 | Unknown DMC

• 2 other identifiers: CPT for PTSD-BPD1R34MH124968-01A1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.

  Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

• Borderline Symptom List 23 (BSL-23) [SELF-REPORT]

  A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).

  Baseline, once a week while in treatment (for 6 weeks)

Secondary Outcomes (27)

• Suicide Attempt Self-Injury Interview (SASII)

  3-weeks, Post-treatment/6-weeks, 3-month follow-up

• Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]

  Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

• Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]

  Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

• Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]

  Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

• State-Trait Anxiety Inventory, Trait Version (STAI-T)

  Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

Study Arms (2)

CPT + SRM

EXPERIMENTAL

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.

Behavioral: Cognitive Processing Therapy with Suicide Risk Management

TAU + SRM

EXPERIMENTAL

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.

Behavioral: Treatment as Usual with Suicide Rick Management

Interventions

Cognitive Processing Therapy with Suicide Risk Management 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.

CPT + SRM

Treatment as Usual with Suicide Rick Management 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.

TAU + SRM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto University: lead
• Toronto Metropolitan University: collaborator
• York University: collaborator
• Stanford University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Palo Alto University

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (2)

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Borderline Personality Disorder; Suicide; Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personality Disorders; Behavioral Symptoms; Behavior

Study Officials

• Janice R Kuo, PhD

  Palo Alto University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariana Guenther, B.A.

CONTACT

650-485-1513; bestlab@paloaltou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a two-phased study. Phase 1 of this investigation will consist of an initial case series in which the CPT+SRM manual will be developed along with fidelity measures. The finalized treatment manual will then be tested in Phase 2, a randomized-controlled trial comparing 12 individual sessions/6 weeks of CPT+SRM versus 6 weeks of TAU+SRM.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)