Cognitive Processing Therapy for PTSD

(CF-CPT Trial)

Not currently recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach to treating PTSD (post-traumatic stress disorder) can improve veterans' lives more effectively than the standard method. The new method, Case Formulation plus Cognitive Processing Therapy, personalizes therapy sessions by focusing on daily functioning and emotional challenges. Veterans dealing with PTSD who are not currently in another trauma-focused therapy may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative therapy methods that could enhance daily life and emotional well-being.

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.

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

Research has shown that Cognitive Processing Therapy (CPT) is a proven treatment for PTSD. Many studies have found it effectively reduces PTSD symptoms and helps with related issues like depression. Evaluations of programs for military and veteran patients have also demonstrated these positive results. CPT tends to have low dropout rates, indicating that most people continue with the treatment and manage it well.

The Case Formulation plus Cognitive Processing Therapy (CF-CPT) builds on CPT's strengths by adding extra strategies to address individual challenges, aiming for even better outcomes. Since CF-CPT improves an already proven therapy, it is expected to be safe. However, there is less specific data on CF-CPT's safety because it is a newer approach.

Both treatments aim to alleviate PTSD symptoms and improve overall well-being. While CF-CPT is still under study, the strong track record of CPT supports confidence in its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for PTSD, which typically involve cognitive therapies like traditional Cognitive Processing Therapy (CPT), the new approach called Case Formulation plus Cognitive Processing Therapy (CF-CPT) is unique. CF-CPT stands out because it expands the traditional CPT protocol to systematically address not just trauma-related beliefs but also the functional impairments that patients experience in daily life. This method provides therapists with more flexibility to adapt sessions based on individual patient needs, allowing deviations from the standard protocol when necessary. Researchers are excited about CF-CPT because it holds the potential to enhance therapy outcomes by providing a more personalized treatment experience, potentially leading to quicker and more comprehensive recovery for those with PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT), a treatment option in this trial, effectively reduces PTSD symptoms. Studies have found significant improvements in PTSD and depression, with benefits lasting even weeks after treatment ends. Another treatment arm in this trial personalizes CPT with a Case Formulation (CF) approach, aiming to boost recovery by directly addressing daily life challenges. This personalized method may increase patient involvement and results without losing the core benefits of traditional CPT. Both methods help individuals change negative beliefs to improve emotional well-being. Overall, evidence well supports CPT and its personalized version for treating PTSD. ^{1 3 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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 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 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 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]

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 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11609254/

Personalizing cognitive processing therapy with a case ... This study investigates whether a personalized, flexible CPT protocol can enhance functional recovery in PTSD treatment without compromising the efficacy of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04407767

A Case Formulation Approach to Cognitive Processing ... This study seeks to improve the clinical effectiveness of CPT by integrating a CF approach that will enable providers to directly target impairments in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy Dozens of clinical trials have demonstrated CPT's efficacy reducing PTSD and related symptoms (e.g., Asmundson et al., 2019, Monson et al., 2006, Resick et al., ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD The review concluded that there is moderate strength of evidence to support the efficacy of CPT for reduction of PTSD symptoms, depression symptoms, and loss ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/7/6/e014292

Study protocol for a randomised controlled trial of cognitive ... The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40947656/

Cognitive processing therapy for posttraumatic stress ... Among the 23 participants available at follow-up, 82.6% (n = 19) met good end-state functioning for PTSD, and none met the criteria for PTSD.