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.
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.
12345What 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.
12367Is 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.
12678Eligibility 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
+1 more
Exclusion Criteria
EU individuals
Severe impairments in written and aural comprehension
I have a severe illness that could be life-threatening.
+1 more
Participant Groups
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.
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.
Cognitive Processing Therapy with Suicide Risk Management is already approved in United States, European Union, Canada, Australia 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)
🇦🇺 Approved in Australia as Cognitive Processing Therapy for:
- Posttraumatic Stress Disorder (PTSD)
- Borderline Personality Disorder (BPD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Candice M. MonsonToronto, Canada
Palo Alto UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Palo Alto UniversityLead Sponsor
Toronto Metropolitan UniversityCollaborator
York UniversityCollaborator
Stanford UniversityCollaborator
Ryerson UniversityCollaborator
National Institute of Mental Health (NIMH)Collaborator
References
Treating Veterans at Risk for Suicide: An Examination of the Safety, Tolerability, and Outcomes of Cognitive Processing Therapy. [2022]Individuals with posttraumatic stress disorder (PTSD) are at increased risk for suicidal thoughts and behaviors; however, clinicians often report apprehension about recommending trauma-focused therapy to patients with an increased risk of suicide. The present study aimed to evaluate the safety, tolerability, and response to cognitive processing therapy (CPT) among a sample of military veterans with PTSD and increased suicide risk. A secondary aim was to provide a clinically useful definition of high suicide risk. Chart review was used to classify the suicide risk level of 290 veterans who participated in CPT at a Veterans Affairs clinic. Treatment outcomes in veterans with different suicide risk levels were also gathered and compared. Over 50% (n = 155) of the sample demonstrated increased suicide risk, and 1.0% (n = 3) engaged in suicidal behavior after initiating treatment. To date, hospital records show no suicide deaths since 2016 among clinic patients who received CPT. Suicide risk level was not associated with CPT tolerability, and PTSD symptom change was equivalent across groups, ps = .085-.976. Veterans across groups reported clinically significant reductions in PTSD symptoms. The tested suicide risk categorization schemes performed similarly in differentiating the odds of CPT completion and PTSD symptom reduction. These results suggest that veterans with PTSD and an increased risk of suicide, including those with previous suicide attempts and current ideation, can tolerate and benefit from CPT. Additional variables must be considered to truly determine the acute and imminent suicide risk that would deem CPT to be contraindicated.
EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. [2019]To determine whether group cognitive processing therapy-cognitive only version (CPT-C) is associated with iatrogenic suicide risk in a sample of active duty US Army personnel diagnosed with posttraumatic stress disorder (PTSD). Possible iatrogenic effects considered include the incidence and severity of suicide ideation, worsening of preexisting suicide ideation, incidence of new-onset suicide ideation, and incidence of suicide attempts among soldiers receiving group CPT-C. Comparison with group present-centered therapy (PCT) was made to contextualize findings.
A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. [2021]To compare the outcomes of Seeking Safety (SS) and cognitive processing therapy (CPT) in veterans with PTSD in a specialty clinic of an urban VA medical center. Retrospective chart review of electronic medical records was conducted for 420 veterans with PTSD who received treatment with either CPT (n = 227) or SS (n = 193) in group setting. 1) treatment completion rate, 2) self-reported PTSD symptom severity measured by PTSD checklist (PCL), and 3) additional mental health services received within 12 months after treatment. Data were analyzed for the 160 who had both a pre and post PCL documented in their charts. The final analysis sample included n = 94 for CPT and n = 66 for SS veterans with a mean age of 49.71[SD = 14] years, 24 women [15%]; mean baseline PCL score was 68.41 [9]. Significantly more veterans completed SS treatment (SS, 59 [89%] than CPT, 47 [50%] (p = <.001). However, PCL score decreases were significantly greater for patients who completed CPT treatment than those in SS (treatment x time interaction, 9.60 vs.4.98, respectively; difference, 4.62; t84 = 2.16; p = .02). The patients who received SS used significantly more mental health services of the PTSD clinical team than patients who completed CPT treatment (p = .01). The results of this study demonstrate the need for alternative approaches where dually diagnosed patients would not be delayed in their receipt of trauma-focused care - i.e., where treatment is initiated concurrently rather than sequentially to substance abuse treatment.
Comparing response to cognitive processing therapy in military veterans with subthreshold and threshold posttraumatic stress disorder. [2021]Research suggests that subthreshold posttraumatic stress disorder (PTSD) symptomatology is associated with increased risk for psychological and functional impairment, including increased risk for suicidal ideation. However, it does not appear that any studies to date have investigated whether subthreshold PTSD can effectively be treated with evidence-based, trauma-focused treatment. Accordingly, we tested response to cognitive processing therapy (CPT) in 2 groups of military veterans receiving care at a VA outpatient specialty clinic, 1 with subthreshold PTSD at pretreatment (n = 51) and the other with full, diagnostic PTSD (n = 483). Multilevel analysis revealed that both groups experienced a significant decrease in PTSD symptoms over the course of therapy (the full and subthreshold PTSD groups experienced an average decrease of 1.79 and 1.52 points, respectively, on the PTSD Checklist with each increment of time, which was coded from 0 at pretreatment to 13 at posttreatment). After controlling for pretreatment symptom severity, a between-groups difference was not found. These results suggest that CPT is an effective form of treatment among military veterans, and that its effectiveness does not differ between subthreshold and threshold groups.
Predicting suicidal ideation 3 months following intensive posttraumatic stress disorder treatment. [2023]This study examined whether posttraumatic stress disorder (PTSD) symptom change during a 3- and 2-week intensive treatment program (ITP)-based in cognitive processing therapy was predictive of reduced suicidal ideation (SI) following treatment.
Dissemination and experience with cognitive processing therapy. [2022]Clinical practice guidelines suggest that cognitive behavioral therapies are recommended for the treatment of posttraumatic stress disorder (PTSD). One of these treatments, cognitive processing therapy (CPT), is an evidence-based treatment that has been shown to be effective at treating combat, assault, and interpersonal violence trauma in randomized controlled trials. The Department of Veterans Affairs (VA) Office of Mental Health Services has implemented an initiative to disseminate CPT as part of a broad effort to make evidence-based psychotherapies widely available throughout the VA healthcare system. This article provides an overview of CPT and reviews the efficacy and program evaluation data supporting its use in a variety of settings. In addition, we report on survey data from individuals who have participated in the VA initiative and on outcome data from patients treated by rollout-trained therapists. Our data suggest that many clinicians trained in the rollout show good adoption of the CPT model and demonstrate solid improvements in their patients' PTSD and depressive symptomotology. Finally, we offer recommendations for using CPT in clinical settings.
Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2022]Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment.
Role of Borderline Personality Disorder in the Treatment of Military Sexual Trauma-related Posttraumatic Stress Disorder with Cognitive Processing Therapy. [2022]Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for many, but not all, veterans with posttraumatic stress disorder (PTSD). Understanding the factors that contribute to poorer response to CPT is important for providing the best care to veterans diagnosed with PTSD. Researchers investigating the effectiveness of CPT for individuals with comorbid personality symptoms have found that borderline personality disorder (BPD) characteristics do not negatively affect treatment outcome; however, participants in those studies were not diagnosed with BPD. The current pilot study investigated the effect of a BPD diagnosis on CPT dropout and outcomes. Data were compiled from a larger randomized clinical trial. Twenty-seven female veterans with military sexual trauma-related PTSD received CPT. Dropout was evaluated by treatment completion and number of sessions attended. Treatment outcome was assessed by the Clinician Administered PTSD Scale (CAPS) and the PTSD Checklist (PCL). No significant differences were observed between veterans with and without BPD comorbidity for number of treatment sessions attended, and there was not a significant relationship between comorbidity status and treatment completion. A hierarchical linear modeling approach was used with BPD entered as a level 2 predictor of outcome. In our sample, veterans with BPD had higher PTSD symptom severity on the CAPS at baseline compared to veterans without BPD comorbidity. CPT was effective in reducing PTSD symptoms; however, BPD diagnosis did not influence treatment response over time on the CAPS or PCL. Our results provide initial support for the use of CPT in female veterans with MST-related PTSD and comorbid BPD.