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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230668
• Other study ID #: CPT for PTSD-BPD
• Secondary ID: 1R34MH124968-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Palo Alto University
• Contact: Ariana Guenther, B.A.
• Phone: 650-485-1513
• Email: bestlab[@]paloaltou.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Palo Alto University	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Palo Alto University	National Institute of Mental Health (NIMH), Stanford University, Toronto Metropolitan University, York University

Country where clinical trial is conducted

United States, 

References & 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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Suicide Attempt Self-Injury Interview (SASII)	Assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm since the previous assessment.	3-weeks, Post-treatment/6-weeks, 3-month follow-up
Secondary	Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]	A self-report measure assessing various dimensions of emotion dysregulation (Gratz & Roemer, 2004).	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]	A 33-item scale assessing post-traumatic symptoms, reactions and appraisals. The measure possesses three subscales; negative cognitions related to the self, negative cognitions related to the world, and self-blame cognitions related to the traumatic event.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]	A 21-item, self-report inventory that measures the severity of depression symptomatology. It corresponds closely to DSM-5 depression criteria and is found to be a more reliable measure of depression (Beck & Steer, 1988).	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	State-Trait Anxiety Inventory, Trait Version (STAI-T)	A measure that consists of 20 items for assessing trait anxiety and 20 for assessing state anxiety. It is used to diagnose anxiety and to help distinguish it from depressive syndromes.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]	A 57-item self-report measure that examines the expression, control, and experience of anger (Schamborg, Tully, & Browne, 2016).	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]	A measure that consists of 54 items for assessing role performance in six areas of functioning, including work, social and leisure activities, relationships with extended family, role as a marital partner (if applicable), parental role (if applicable), and role within the family unit.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]	A 32-item self-report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including; guilt cognitions, distress and global guilt.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Suicidal Behaviors Questionnaire-Revised	Scores range from 3 to 18, with 18 being higher suicide risk.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Substance Use Inventory (SUI)	A brief measure with detailed questions regarding participants' use and primary route of different substances they used in the last seven days. The individuals' are also asked about the average dollar amount spent on each drug and in a single day. (Weiss, et al., 1995).	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	PTSD Checklist-5 (PCL-5) [SELF-REPORT]	A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to help screen individuals for PTSD as well as monitor their symptom changes during and after treatment.	Baseline, once a week while in treatment (for 6 weeks)
Secondary	Acceptability of Intervention Measure (AIM)	A 4-item measure which asks therapists and patients about their perceived acceptability of the intervention on a 5-point Likert scale.	Baseline and Post-treatment/6-weeks
Secondary	Treatment sessions attended	Feasibility as measured by number of treatment sessions	Pre-post treatment (6 weeks)
Secondary	Rate of dropout	Feasibility as measured by rate of treatment dropout	Pre-post treatment (6 weeks)
Secondary	Emotional Reactivity and Attentional Biases via Oddball task	Used as a behavioral measure of changes in emotional reactivity and attentional biases- our two propose mechanisms of change in CPT+SRM. The oddball task is computer-based task (Hayes, et al., 2009) designed to measure emotional reactivity and attentional biases. Participants will view a pseudorandom distribution of brief presentations of emotionally-salient distractors (negative images depicting mutilations, burn victims, attacks, sick individuals), neutral distractors (matched with negative images for luminance, presence of human figures, chromatic features), baseline standards (squares), and attention "targets" (circles) in an event-related design. Participants will be instructed to press the same button for all stimuli, but a different button for attention targets. Behavioral changes associated with emotional reactivity and attention bias will be assessed using response latency and accuracy scores for emotional and attention targets, respectively.	Baseline, Post-treatment/6-weeks, 3-months follow-up
Secondary	Mental Health Involvement Scale [SELF-REPORT]	A 9-item measure used to inquire about other ancillary services (e.g., group treatment, couples/family therapy) that participants are receiving throughout the study. This is a measure developed and used in prior research by the investigative team, but currently does not have published psychometric properties.	Post-treatment/6-weeks
Secondary	Measure of CPT+SRM Uptake [SELF-REPORT]	Measures uptake of the treatment using an adapted measure from LoSavio, et al. (2019). This brief survey will assess clinicians' ongoing use of CPT+SRM since their participation in the study (e.g., whether they continue to offer CPT+SRM, the number of clients they have offered CPT+SRM to, average number of sessions attended, etc.) and further inform whether our training methods and treatment will have a lasting impact on practice approaches in community settings. There are no psychometric data available for this questionnaire.	9-months after concluding treatment with the last study participant
Secondary	Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)	Safety of the treatment will be monitored via unanticipated problems involving risk to subjects or others (UPIRSO) that occur throughout treatment and the number of mental health hospitalizations.	Baseline, 3-weeks, Post-treatment/6-weeks
Secondary	The International Personality Disorder Exam (IPDE, BPD only)	A well-established diagnostic instrument used by the World Health Organization, will be used to identify the presence and severity of BPD. The IPDE also allows for a dimensional assessment of BPD.	Baseline
Secondary	The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)	Used to obtain other DSM-5 diagnoses.	Baseline
Secondary	The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)	A semi-structured interview, will assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm.	Baseline
Secondary	A Demographic Form [SELF-REPORT]	Used in previous PTSD treatment studies will also be used to measure a range of demographic data.	Baseline
Secondary	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. --	A 24-item self-report measure that evaluates levels of shame in the context of one's trauma.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Patient Health Questionnaire - 9 (PHQ-9)	A 9-item self-report measure that evaluates severity of depression symptoms.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	Generalized Anxiety Disorder - 7 (GAD7)	A 7-item self-report measure that evaluates severity of generalized anxiety symptoms.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)	A 12-item self-report measure of disability across six domains (understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Secondary	DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult	A 23-item self-report measure of psychiatric symptoms that cut across diagnostic categories.	Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up