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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Cognitive Processing Therapy for PTSD-BPD is an effective treatment?

The available research shows that Cognitive Processing Therapy (CPT) is effective for treating PTSD in veterans, even those at high risk for suicide. In one study, veterans who underwent CPT reported significant reductions in PTSD symptoms, and there were no suicide deaths among patients who received CPT since 2016. Another study found that while more veterans completed an alternative treatment called Seeking Safety, those who completed CPT had greater reductions in PTSD symptoms. This suggests that CPT can be more effective in reducing PTSD symptoms compared to some other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Cognitive Processing Therapy for PTSD-BPD?

Research shows that Cognitive Processing Therapy (CPT) is effective in reducing PTSD symptoms in veterans, even those at high risk for suicide. Studies indicate that CPT can be safely used without increasing suicide risk, and it leads to significant improvements in PTSD symptoms. ^{1 2 3 4 5}

What safety data exists for Cognitive Processing Therapy for PTSD-BPD?

Cognitive Processing Therapy (CPT) has been evaluated for safety in various studies. One study on active duty military personnel found no significant iatrogenic suicide risk associated with group CPT-C. Another study on veterans with PTSD and increased suicide risk showed that CPT was well-tolerated, with no suicide deaths reported since 2016 among those treated. Veterans experienced significant reductions in PTSD symptoms, and suicide risk level did not affect treatment tolerability. Additionally, a comparison study found that while more veterans completed Seeking Safety treatment, those who completed CPT had greater reductions in PTSD symptoms. Overall, CPT is considered safe and effective for individuals with PTSD, including those at increased risk of suicide. ^{1 2 3 6 7}

Is Cognitive Processing Therapy (CPT) safe for individuals with PTSD and increased suicide risk?

Research indicates that Cognitive Processing Therapy (CPT) is generally safe for individuals with PTSD, including those with increased suicide risk. In a study of military veterans, only 1% engaged in suicidal behavior after starting CPT, and there were no suicide deaths reported among patients who received CPT since 2016. This suggests that CPT is tolerable and can be safely used in this population. ^{1 2 3 6 7}

Is Cognitive Processing Therapy with Suicide Risk Management a promising treatment for PTSD and BPD?

Yes, Cognitive Processing Therapy with Suicide Risk Management is a promising treatment for PTSD and BPD. It has been shown to help reduce PTSD symptoms in veterans, even those at high risk for suicide. The therapy is well-tolerated and effective, and it can be used safely with individuals who have both PTSD and BPD. ^{1 2 6 7 8}

How is the treatment Cognitive Processing Therapy with Suicide Risk Management unique for PTSD-BPD?

Cognitive Processing Therapy with Suicide Risk Management (CPT+SRM) is unique because it combines trauma-focused therapy with specific strategies to manage suicide risk, making it suitable for individuals with PTSD who are at increased risk of suicide. This approach is particularly beneficial for veterans and those with comorbid conditions like borderline personality disorder (BPD), as it has been shown to effectively reduce PTSD symptoms without increasing suicide risk. ^{1 2 6 7 8}

Research Team

Janice R Kuo, PhD

Principal Investigator

Palo Alto University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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) 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treating Veterans at Risk for Suicide: An Examination of the Safety, Tolerability, and Outcomes of Cognitive Processing Therapy. [2022]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comparing response to cognitive processing therapy in military veterans with subthreshold and threshold posttraumatic stress disorder. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Predicting suicidal ideation 3 months following intensive posttraumatic stress disorder treatment. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

8. United States 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. [2022]