Cognitive Processing Therapy for PTSD

(CF-CPT Trial)

Recruiting at 7 trial locations

Overseen By Tara E Galovski, PhD MA BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicidal ideation, Homicidality, Mania, Psychosis, Serious substance abuse, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from PTSD, a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of lingering effects of physical injury; and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being even decades after exposure to the traumatic event. Perhaps spurred by the President's New Freedom Commission on Mental Health, psychosocial rehabilitation has shifted from the periphery in mental health recovery models to a more primary focus in clinical settings, including recommendations for use of psychosocial rehabilitation techniques in trauma-focused mental health care. Support for the efficacy of psychosocial rehabilitation techniques in PTSD recovery programs has burgeoned in recent years and data supporting psychological treatments for PTSD has increased exponentially, yet the two approaches to recovery have largely remained independent. Cognitive Processing Therapy (CPT), the evidence-based psychotherapy (EBP) for PTSD most frequently delivered within VHA, yields large magnitude reductions in primary PTSD outcomes. Corresponding gains in occupational, social, leisure, and sexual functioning, and in health-related concerns have also been demonstrated. Despite CPT's effectiveness, there is room for improvement in overall outcomes and patient engagement. Further, improvements in functioning and quality of life are more modest than those observed in PTSD and associated mental health symptoms. Prior work suggests that unaddressed difficulties in functioning contribute to premature dropout from EBPs for PTSD among Veterans. Directly targeting impairments associated with psychosocial functioning has the potential to substantially increase the scope of recovery beyond the core symptoms of PTSD and facilitate greater patient engagement, resulting in more Veterans benefitting from CPT. Modifying the CPT protocol to personalize the intervention for the individual patient has resulted in better overall response rates for a wider variety of patient populations suffering from complicated clinical presentations. Case formulation (CF) is a well-established approach to cognitive-behavioral treatment that facilitates a collaborative process between providers and patients to guide the tailoring of treatment to meet idiosyncratic patient needs. Integrating CF strategies into the existing CPT protocol will enable providers to personalize CPT to directly address impairment in functioning as well as provide the latitude to directly intervene with the complex challenges that threaten optimal outcomes within the context of trauma-focused therapy. CF-integrated CPT (CF-CPT) expands and enhances the CPT protocol to facilitate a personalized and flexible approach to treating PTSD that prioritizes the administration of the full dose of CPT while expanding the protocol to directly target important domains of functioning and result in more holistic outcomes. This controlled treatment outcome trial will randomize a national sample of CPT providers (Veteran n = 200; provider n = 50) to either deliver CF-CPT or CPT to compare the relative effectiveness of CF-CPT to CPT in improving primary outcomes, including Veterans' psychosocial functioning, quality of life and well-being over the course of treatment and 3-month follow-up as compared to Veterans who receive standard CPT. Further, Veterans who receive CF-CPT will demonstrate greater reductions in PTSD and depression over the course of treatment and 3-month follow-up than those who receive CPT. This study also seeks to determine the effectiveness of CF-CPT as compared to CPT in improving Veterans' treatment engagement (CF-CPT will demonstrate higher rates of Veteran treatment completion than CPT). This study will valuate CF-CPT's indirect impact on Veterans' psychosocial functioning and PTSD/depression symptomology Change in functioning, quality of life, and well-being \& PTSD and depression will be associated with improvement in the idiosyncratic clinical challenges targeted by the CF. This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe the frequency and type of the clinical and rehabilitative needs of the Veterans and the type and duration of divergences (e.g. rehabilitative techniques) made by providers.

Will I have to stop taking my current medications?

You can continue taking your current psychiatric medications as long as the dose has been stable for one month before joining the trial.

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

Research shows that Cognitive Processing Therapy (CPT) significantly reduces PTSD and depression symptoms, with many participants no longer meeting PTSD criteria after treatment. Improvements were maintained over time, and the therapy was well-received by participants. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) safe for humans?

Cognitive Processing Therapy (CPT) is widely regarded as a safe treatment for post-traumatic stress disorder (PTSD) and has been effectively used in various populations, including military veterans and active-duty personnel. ^{1 3 6 7 8}

How does Cognitive Processing Therapy with Case Formulation differ from other PTSD treatments?

Cognitive Processing Therapy (CPT) with Case Formulation is unique because it combines traditional CPT with an explicit case formulation approach, which tailors the therapy to individual needs and guides the treatment length and components. This personalized approach helps address specific unhelpful beliefs related to trauma, leading to significant reductions in PTSD symptoms and depression. ^{2 3 5 6 9}

Research Team

Shannon M. Kehle-Forbes, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Tara Ellen Galovski, PhD MA BS

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for US Veterans with PTSD who are not currently experiencing severe mental health issues like active suicidal thoughts, homicidal tendencies, mania, psychosis, or serious substance abuse needing immediate attention. They shouldn't be in another trauma-focused therapy but can continue stable psychiatric medications.

Exclusion Criteria

Psychosis

I do not need immediate medical help for drug or alcohol use.

My psychiatric medication dose has been stable for at least one month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy (CPT) or Case Formulation plus CPT (CF-CPT) over 12 sessions, focusing on cognitive processing and addressing impairments in functioning.

12 weeks

12 visits (in-person)

Mid-Treatment Assessment

Assessment of progress and adjustment of treatment as necessary, including monitoring of COTOs for CF-CPT group.

1 week

1 visit (in-person or virtual)

Post-Treatment Assessment

Evaluation of treatment outcomes and psychosocial functioning two weeks after treatment completion.

2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-month intervals.

3 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• Case Formulation plus Cognitive Processing Therapy
• Cognitive Processing Therapy

Trial Overview The study compares two methods of treating PTSD: standard Cognitive Processing Therapy (CPT) and a personalized version that includes Case Formulation (CF-CPT). It aims to see if CF-CPT improves psychosocial functioning and quality of life more than CPT alone over treatment and follow-up periods.

Participant Groups

Group I: Case Formulation plus Cognitive Processing Therapy Experimental Treatment 1 Intervention

The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.

Group II: Cognitive Processing Therapy Active Control 1 Intervention

CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Cognitive processing therapy (CPT) is an effective treatment for PTSD in veterans, but many do not complete the full program, often receiving only four sessions instead of the full 12, highlighting the need for a more efficient treatment format.

A study involving 270 veterans used a fractional factorial design to identify the most effective components of CPT, aiming to create a shorter version that could reduce dropout rates and improve treatment accessibility for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Sripada, RK., Peterson, CL., Dziak, JJ., et al.[2023]

Cognitive processing therapy (CPT) significantly improved various domains of psychosocial functioning in 78 women with PTSD, regardless of whether they received the full treatment or just its components.

Reductions in PTSD symptoms, particularly emotional numbing and hyperarousal, were strongly associated with improvements in psychosocial functioning, highlighting the importance of addressing these symptoms during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors. Shnaider, P., Vorstenbosch, V., Macdonald, A., et al.[2018]

Cognitive processing therapy (CPT) has been shown to be an effective treatment for PTSD in active duty military personnel, as demonstrated in a case study of a service member who underwent 13 therapy sessions.

The case study highlights significant progress in reducing PTSD symptoms and achieving treatment goals, showcasing the practical application of CPT in an outpatient setting and addressing clinical challenges faced during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study of Cognitive Processing Therapy for a Military Medic With Posttraumatic Stress Disorder. Wiley, RE.[2020]

Cognitive Processing Therapy (CPT) significantly improved PTSD and depression symptoms in 19 sexual assault survivors after 12 weekly group sessions, with benefits maintained for 6 months post-treatment.

In contrast, a comparison group of 20 individuals who waited for therapy showed no improvement, highlighting the efficacy of CPT in treating PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. Resick, PA., Schnicke, MK.[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) 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]

This study aims to evaluate the efficacy of Cognitive Processing Therapy (CPT) for treating PTSD in Japanese patients through a 16-week trial involving 58 participants, comparing CPT combined with usual treatment against usual treatment alone.

The primary outcome will be measured using the Clinician-Administered PTSD Scale, with an expected effect size of 1.4, indicating that CPT may significantly improve PTSD symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. Ito, M., Horikoshi, M., Resick, PA., et al.[2019]

Cognitive Processing Therapy (CPT) effectively reduced PTSD symptoms in a study of 18 patients, with 15 participants showing statistically significant improvements in their symptom scores.

The study highlights the successful adaptation of the CPT protocol to address specific barriers faced by trauma survivors, demonstrating its potential for broader implementation in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. Zappert, LN., Westrup, D.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. [2023]

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

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors. [2018]

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

A Case Study of Cognitive Processing Therapy for a Military Medic With Posttraumatic Stress Disorder. [2020]

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

Cognitive processing therapy for sexual assault victims. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Using Explicit Case Formulation to Improve Cognitive Processing Therapy for PTSD. [2019]

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. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. [2019]

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

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]