Cognitive Processing Therapy for PTSD-BPD

Recruiting at 1 trial location

Overseen By Ariana Guenther, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto University

Disqualifiers: Acute mania, Psychosis, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for individuals with both PTSD (Posttraumatic Stress Disorder) and BPD (Borderline Personality Disorder). The researchers aim to determine if combining Cognitive Processing Therapy with a Suicide Risk Management strategy reduces symptoms more effectively than standard treatment. Participants will be randomly assigned to two groups: one receiving the new combined therapy and the other receiving standard care, both delivered via telehealth. This trial suits those in the Bay Area, CA, diagnosed with both PTSD and BPD and open to teletherapy sessions. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does not mention a requirement to stay on existing medications either.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Processing Therapy (CPT) is generally safe for people with PTSD, including those at higher risk for suicide. In one study, most participants tolerated CPT well, experiencing no severe side effects. However, since this trial involves individuals with both PTSD and Borderline Personality Disorder (BPD), it is important to recognize that these conditions can increase feelings of distress.

To manage potential risks like emotional distress or self-harm, the researchers have added a component called Suicide Risk Management (SRM). The safety data collected so far suggest that this approach can be safely used in online therapy sessions, which is promising for making the treatment more accessible.

Overall, while some emotional discomfort might occur during therapy, the treatment is considered safe, especially with SRM in place to address any serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine Cognitive Processing Therapy (CPT) with Suicide Risk Management (SRM) in a novel way to address the dual challenges of PTSD and Borderline Personality Disorder (BPD). Unlike standard care options, which typically involve separate therapy sessions for PTSD and BPD, this approach integrates both conditions into a cohesive treatment plan. The use of teletherapy also makes these treatments more accessible, allowing patients to receive care from the comfort of their homes. Additionally, CPT + SRM offers a more intensive schedule with twice-weekly sessions, which may lead to faster and more robust outcomes compared to traditional weekly therapy sessions. This integrated approach could revolutionize how we address the complex interplay of PTSD and BPD, providing targeted support for those at risk of suicide.

What evidence suggests that Cognitive Processing Therapy with Suicide Risk Management might be an effective treatment for PTSD-BPD?

Research has shown that Cognitive Processing Therapy (CPT) can reduce PTSD symptoms, even in individuals with complex needs like Borderline Personality Disorder (BPD). In this trial, participants will receive either CPT with Suicide Risk Management (SRM) or Treatment as Usual with SRM. For those with both PTSD and BPD, early studies indicate that CPT can help manage strong emotions and cognitive issues caused by these conditions. Adding SRM to CPT aims to enhance safety and increase treatment effectiveness. Evidence from similar treatments suggests that this combined approach is both practical and beneficial. Overall, CPT with SRM offers a promising way to address the challenges of having both PTSD and BPD. ^{1 2 6 7 8}

Who Is on the Research Team?

Janice R Kuo, PhD

Principal Investigator

Palo Alto University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must reside in the Bay Area, CA

I have been diagnosed with PTSD and BPD.

Must be willing to be audio- or videorecorded for assessment and treatment sessions

Exclusion Criteria

EU individuals

Severe impairments in written and aural comprehension

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy augmented with Suicide Risk Management (CPT+SRM) or Treatment as Usual (TAU) + SRM via telehealth

6 weeks

12 sessions for CPT+SRM, 6 sessions for TAU+SRM

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments at 3 weeks, post-treatment, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy with Suicide Risk Management
• Treatment as Usual with Suicide Rick Management

Trial Overview 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.

How Is the Trial Designed?

Group I: TAU + SRM Experimental Treatment 1 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 + SRM Experimental Treatment 1 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.

Cognitive Processing Therapy with Suicide Risk Management is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)
• Borderline Personality Disorder (BPD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)
• Borderline Personality Disorder (BPD)

Approved in Canada as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)
• Borderline Personality Disorder (BPD)

Who Is Running the Clinical Trial?

Palo Alto University

Lead Sponsor

Trials

14

Recruited

8,100+

Toronto Metropolitan University

Collaborator

Trials

95

Recruited

19,300+

York University

Collaborator

Trials

64

Recruited

521,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Ryerson University

Collaborator

Trials

77

Recruited

7,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

Cognitive Processing Therapy (CPT) was effective in reducing PTSD symptoms in female veterans with military sexual trauma, regardless of whether they had comorbid borderline personality disorder (BPD).

The study found no significant differences in treatment dropout or completion rates between veterans with and without BPD, suggesting that CPT can be safely administered to those with this comorbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Borderline Personality Disorder in the Treatment of Military Sexual Trauma-related Posttraumatic Stress Disorder with Cognitive Processing Therapy. Holder, N., Holliday, R., Pai, A., et al.[2022]

In a study of 290 military veterans with PTSD, over 50% were identified as having an increased risk of suicide, yet only 1% engaged in suicidal behavior after starting cognitive processing therapy (CPT), indicating that CPT is safe and tolerable for this population.

Veterans with varying levels of suicide risk experienced similar reductions in PTSD symptoms after CPT, suggesting that trauma-focused therapy can be beneficial even for those at higher risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Veterans at Risk for Suicide: An Examination of the Safety, Tolerability, and Outcomes of Cognitive Processing Therapy. Roberge, EM., Harris, JA., Weinstein, HR., et al.[2022]

In a study of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

Cognitive processing therapy (CPT) effectively reduces PTSD symptoms in both military veterans with subthreshold PTSD (51 participants) and those with full PTSD (483 participants), showing similar levels of improvement over treatment.

Both groups experienced significant symptom decreases, averaging 1.79 points for full PTSD and 1.52 points for subthreshold PTSD on the PTSD Checklist, indicating that CPT is beneficial regardless of the severity of PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing response to cognitive processing therapy in military veterans with subthreshold and threshold posttraumatic stress disorder. Dickstein, BD., Walter, KH., Schumm, JA., et al.[2021]

In a study of 108 active duty US Army personnel with PTSD, both group cognitive processing therapy-cognitive only version (CPT-C) and group present-centered therapy (PCT) significantly reduced rates of suicide ideation, with improvements maintained for up to 12 months post-treatment.

There were no reported suicide attempts during or after treatment in either group, and exacerbation of preexisting suicide ideation was uncommon, suggesting that group CPT-C is safe and does not increase suicide risk among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Bryan, CJ., Clemans, TA., Hernandez, AM., et al.[2019]

Veterans undergoing a 3-week (n=274) or 2-week (n=177) intensive treatment program for PTSD showed moderate reductions in suicidal ideation (SI), with about 65% of those reporting SI at baseline experiencing reductions post-treatment.

Improvements in PTSD symptoms during treatment were linked to lower SI at a 3-month follow-up, indicating that intensive cognitive processing therapy can effectively reduce both PTSD symptoms and suicidal thoughts in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting suicidal ideation 3 months following intensive posttraumatic stress disorder treatment. Smith, DL., Tharaud, JB., Pridgen, SA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.

2. stanfordhealthcare.org stanfordhealthcare.org/trials/c/NCT04230668.html

Cognitive Processing Therapy (CPT) for Posttraumatic ... A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD. Eligibility ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02574429

CPT Group for DBT Clients With Co-Occurring Borderline ... This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5325773/

Cognitive Behavioral Therapy for Posttraumatic Stress ... CBT for PTSD was feasible and tolerated in individuals with SMI, BPD, and PTSD, and associated with improvements in PTSD symptoms and related outcomes.

6. withpower.com withpower.com/trial/phase-stress-disorders-post-traumatic-8-2021-a92a2

Cognitive Processing Therapy for PTSD-BPD Research indicates that Cognitive Processing Therapy (CPT) is generally safe for individuals with PTSD, including those with increased suicide risk. In a study ...

7. nimh.nih.gov nimh.nih.gov/health/trials/suicide-prevention

Suicide Prevention - National Institute of Mental Health (NIMH) 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 ...

8. med.stanford.edu med.stanford.edu/content/sm/clinicaltrials/trials-by-condition-nav/healthyvolunteers.html?start=440

Browse Trials Accepting Healthy Volunteers | Clinical Trials ... The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment.