What side effects are associated with this type of intervention?

Common treatments for Borderline Personality Disorder (BPD) like Dialectical Behavior Therapy (DBT), Cognitive Behavioral Therapy (CBT), and Schema Therapy primarily involve emotional and cognitive work, which can lead to emotional distress, increased anxiety, and temporary worsening of symptoms as patients process difficult emotions. When pharmacotherapy is used, side effects may include weight gain, sedation, sexual dysfunction, and metabolic changes.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Borderline Personality Disorder (BPD). Treatment typically involves psychotherapy, with several effective options such as Dialectical Behavior Therapy (DBT), Cognitive Behavioral Therapy (CBT), and Mentalization-Based Therapy (MBT). These therapies focus on managing emotional intensity and cognitive dysfunction, similar to the goals of Cognitive Processing Therapy augmented with Suicide Risk Management (CPT+SRM) being studied for PTSD and BPD. Medications may be used off-label to manage specific symptoms like mood swings, depression, or anxiety, but they are not approved specifically for BPD.

What other types of research exist?

Promising, novel alternatives to CPT+SRM for treating Borderline Personality Disorder (BPD) include: 1) Dialectical Behavior Therapy Skills Training Group (DBTSTG), which has shown effectiveness in reducing depression and suicide attempts, and 2) Mindfulness-Based Cognitive Therapy for Preventing Suicide (MBCT-S), which has demonstrated a reduction in the number of suicide events and psychiatric hospitalizations. Both therapies target emotional regulation and cognitive processes, making them suitable alternatives for BPD patients.

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Cognitive Processing Therapy for PTSD-BPD

N/A

Recruiting

Led By Candice M Monson, PhD

Research Sponsored by Palo Alto University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current DSM-5 diagnosis of PTSD and BPD

Aged 18-65 years

Must not have

Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-weeks, post-treatment/6-weeks, 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment combining Cognitive Processing Therapy with Suicide Risk Management for people with both PTSD and BPD. The goal is to provide a shorter, more effective treatment that addresses intense emotions and negative thinking patterns. The study will evaluate how well this approach works. Cognitive Processing Therapy (CPT) has been shown to be effective in reducing PTSD symptoms among survivors of sexual assault and other traumas.

Who is the study for?

This trial is for adults aged 18-65 in the Bay Area with PTSD and BPD who are willing to be recorded during sessions. It's not for those with severe comprehension issues, EU residents, life-threatening illnesses, acute mania or psychosis, or intellectual disabilities.

What is being tested?

The study tests Cognitive Processing Therapy enhanced with Suicide Risk Management (CPT+SRM) against usual treatment plus SRM. Conducted via telehealth over 12 sessions, it aims to improve PTSD-BPD symptoms by targeting emotional intensity and cognitive dysfunction.

What are the potential side effects?

Participants may experience emotional distress or discomfort when discussing trauma and mental health issues. There's also a risk of increased suicidality or self-harm which will be managed through a suicide risk protocol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD and BPD.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a severe illness that could be life-threatening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-weeks, post-treatment/6-weeks, 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-weeks, post-treatment/6-weeks, 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-weeks, post-treatment/6-weeks, 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

A Demographic Form [SELF-REPORT]

Acceptability of Intervention Measure (AIM)

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

+24 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TAU + SRMExperimental Treatment1 Intervention

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.

Group II: CPT + SRMExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Borderline Personality Disorder (BPD) include Dialectical Behavior Therapy (DBT), Mentalization-Based Therapy (MBT), Transference-Focused Therapy (TFT), and Cognitive Behavioral Therapy (CBT). DBT focuses on managing suicidal and dangerous behaviors, improving emotional regulation, and enhancing quality of life. MBT helps patients observe their mental states and develop alternative perspectives, improving emotional intensity and cognitive dysfunction. TFT addresses distorted perceptions of significant others through exploration and confrontation, aiming to correct emotional and cognitive distortions. CBT targets distorted cognitions and behaviors to improve social and emotional functioning. These therapies are crucial for BPD patients as they address core symptoms such as emotional dysregulation and cognitive distortions, which are also the focus of CPT+SRM in treating PTSD and BPD.