Clinical trial NCT04230668: Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)
Official title: A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Borderline Personality Disorder
Keywords: Cognitive Processing Therapy
Suicide Risk Management
Suicide
Self-harm
Lead sponsor: Palo Alto University
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
name: York University
name: Stanford University
name: National Institute of Mental Health (NIMH)
First posted: 2020-01-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
timeFrame: Baseline, once a week while in treatment (for 6 weeks)
Secondary outcomes:
measure: Suicide Attempt Self-Injury Interview (SASII)
timeFrame: 3-weeks, Post-treatment/6-weeks, 3-month follow-up
measure: Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: State-Trait Anxiety Inventory, Trait Version (STAI-T)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Suicidal Behaviors Questionnaire-Revised
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Substance Use Inventory (SUI)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: PTSD Checklist-5 (PCL-5) [SELF-REPORT]
timeFrame: Baseline, once a week while in treatment (for 6 weeks)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Baseline and Post-treatment/6-weeks
measure: Treatment sessions attended
timeFrame: Pre-post treatment (6 weeks)
measure: Rate of dropout
timeFrame: Pre-post treatment (6 weeks)
measure: Emotional Reactivity and Attentional Biases via Oddball task
timeFrame: Baseline, Post-treatment/6-weeks, 3-months follow-up
measure: Mental Health Involvement Scale [SELF-REPORT]
timeFrame: Post-treatment/6-weeks
measure: Measure of CPT+SRM Uptake [SELF-REPORT]
timeFrame: 9-months after concluding treatment with the last study participant
measure: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks
measure: The International Personality Disorder Exam (IPDE, BPD only)
timeFrame: Baseline
measure: The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)
timeFrame: Baseline
measure: The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
timeFrame: Baseline
measure: A Demographic Form [SELF-REPORT]
timeFrame: Baseline
measure: Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: Generalized Anxiety Disorder - 7 (GAD7)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
measure: DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
timeFrame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Janice R Kuo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.
citation: Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.