Cognitive Behavioral Therapy for Chronic Pelvic Pain Syndrome

(EPPIC Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Jeffrey Lackner, PsyD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: State University of New York at Buffalo

Disqualifiers: Neurological conditions, Urethral stricture, Pelvic malignancy, Major psychiatric disorder, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a brief cognitive behavioral therapy to help people with chronic pelvic pain. It aims to teach skills for managing pain and symptoms with minimal clinician help. The study focuses on adults with conditions like interstitial cystitis and chronic prostatitis, which are hard to treat with current methods. The therapy works by changing how patients think about and cope with their pain. Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for chronic pain in numerous studies.

Do I need to stop my current medications to join the trial?

You don't have to stop your current medications, but you should not start any new ones until after the initial 2-week pre-treatment baseline period, unless it's medically necessary.

What data supports the effectiveness of the treatment Minimal Contact-Cognitive Behavior Therapy for chronic pelvic pain syndrome?

Research suggests that psychological therapies, including cognitive behavioral therapy (CBT), can reduce pain in women with chronic pelvic pain when compared to no treatment, although the evidence is not conclusive. Additionally, multidisciplinary approaches that combine psychological and physical therapies show promise in managing chronic pelvic pain. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for humans?

Cognitive Behavioral Therapy (CBT) is generally considered safe for humans, as it is a non-invasive treatment that focuses on changing thought patterns and behaviors. It is widely used for various conditions and does not involve medication, reducing the risk of physical side effects. ^{3 6 7 8 9}

How is Minimal Contact-Cognitive Behavior Therapy (MC-CBT) different from other treatments for chronic pelvic pain syndrome?

Minimal Contact-Cognitive Behavior Therapy (MC-CBT) is unique because it focuses on changing negative thought patterns and behaviors related to pain, and it can be delivered remotely, making it more accessible to people in rural or underserved areas. Unlike some other treatments, it does not rely on medication and can be adapted to fit into primary care settings, offering a flexible and cost-effective option for managing chronic pain. ^{10 11 12 13 14}

Research Team

Jeffrey Lackner, PsyD

Principal Investigator

University at Buffalo (SUNY)

Eligibility Criteria

The EPPIC study is for adults aged 18-70 with a doctor-confirmed diagnosis of chronic pelvic pain syndromes like interstitial cystitis or chronic prostatitis. Participants must have had pelvic pain for at least six months, be willing to attend therapy sessions, and not start new medications during the initial study period.

Inclusion Criteria

My gender, race, or ethnicity does not limit my participation.

I have been diagnosed with IC/BPS or CP/CPPS by a specialist.

I understand the study and can give my consent.

Exclusion Criteria

I do not have any health conditions that would make it unsafe for me to participate in this study.

I have a neurological condition like MS that affects my bladder.

Has a major psychiatric disorder which would impede conduct of the clinical study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-session cognitive behavioral therapy or education/support control over a 10-week acute phase

10 weeks

4 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months post-treatment

Treatment Details

Interventions

• Minimal Contact-Cognitive Behavior Therapy (Cognitive Behavioral Therapy)
• Patient Education/Support (Behavioural Intervention)

Trial Overview This trial tests an ultra-brief cognitive behavioral therapy (CBT) designed to treat various urologic chronic pain syndromes. It involves four sessions aimed at easing dissemination and reducing treatment complexity compared to existing therapies.

Participant Groups

Group I: Minimal Contact-Cognitive Behavior Therapy Experimental Treatment 1 Intervention

CBT is a goal-focused, learning-based treatment that teaches practical self-management tools and strategies targeting biobehavioral factors that aggravate pelvic pain and urinary symptoms

Group II: Education/Support Active Control 1 Intervention

EDU emphasizes the empowering therapeutic benefits that come from the common across empirically-validated drug or non-drug treatment such as being listened to, support, receipt of science-based information, mobilization of hope, and the establishment of a strong patient-doctor relationship working toward shared goals

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Dr. Jonathan Slonin

State University of New York at Buffalo

Chief Medical Officer since 2020

MD from University of Miami, MBA from George Washington University

Stacy Knapper

State University of New York at Buffalo

Chief Executive Officer since 2023

BSEE from University of Puerto Rico-Mayagüez, MS in Management from Rensselaer Polytechnic Institute

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Findings from Research

A systematic review of four randomized controlled trials found that psychological therapies can lead to a significant reduction in chronic pelvic pain (CPP) compared to no treatment, with notable improvements in pain scores at both 3 and 6 months.

Despite these findings, the evidence is not strong enough to definitively conclude the effectiveness of psychological interventions on self-reported pain scores in women with CPP, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological therapies for chronic pelvic pain: systematic review of randomized controlled trials. Champaneria, R., Daniels, JP., Raza, A., et al.[2018]

Chronic pelvic pain (CPP) in women is often linked to a history of trauma and is frequently comorbid with psychiatric conditions, yet most intervention studies do not specifically address trauma in their treatment approaches.

Out of 28 studies reviewed, only a few acknowledged trauma's role, highlighting a significant gap in the literature; future research should focus on integrating trauma considerations into interventions for CPP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Trauma and Mental Health in the Treatment of Chronic Pelvic Pain: A Systematic Review of the Intervention Literature. Panisch, LS., Tam, LM.[2021]

Chronic pelvic pain syndrome (CPPS) is challenging to treat due to its unclear causes, but non-pharmacological approaches like acupuncture and manual therapy show promise in managing symptoms, as highlighted in a review of various studies.

The review suggests that improvements in pain may be linked to changes in the body's inflammatory responses and sensitivity, emphasizing the need for evidence-based complementary and alternative medicine (CAM) practices in treating CPPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Review of Neuromusculoskeletal Complementary and Alternative Approaches for the Treatment of Chronic Pelvic Pain Syndrome. Marks, SK., Rodriguez, NA., Shah, A., et al.[2022]

Chronic pelvic pain (CPP) significantly affects women's quality of life, and while physiotherapy is recommended as a treatment, the evidence supporting its effectiveness is limited and primarily derived from small, non-randomized studies.

Some evidence suggests that multidisciplinary interventions, including physiotherapy and Mensendieck somatocognitive therapy, may help manage CPP, but more high-quality randomized clinical trials are needed to establish definitive treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does evidence support physiotherapy management of adult female chronic pelvic pain? A systematic review. Loving, S., Nordling, J., Jaszczak, P., et al.[2019]

Recent studies suggest that complementary and alternative medicine (CAM) treatments, such as exercise-based therapies, pelvic floor physical therapy, acupuncture, and cognitive behavioral therapy, may improve outcomes for women with chronic pelvic pain (CPP), but more rigorous studies are needed to confirm their efficacy.

Preliminary evidence indicates that non-opioid alternatives like oral cannabinoids could be a safe and effective option for managing CPP, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and Alternative (CAM) Treatment Options for Women with Pelvic pain. Srinivasan, M., Torres, JE., McGeary, D., et al.[2022]

In a study of 273 women with chronic pelvic pain, a history of adolescent or adult sexual abuse was linked to greater pain-related disability, with an odds ratio of 2.39, indicating a significant impact on their ability to function despite not affecting pain severity directly.

Both physical and sexual abuse histories were associated with higher levels of depressive symptoms, suggesting that the psychological effects of abuse may be more influential on mental health than the experience of pain itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of abuse and its relationship to pain experience and depression in women with chronic pelvic pain. As-Sanie, S., Clevenger, LA., Geisser, ME., et al.[2021]

Biofeedback therapy significantly improved symptoms in 60 out of 62 patients with chronic pelvic pain syndrome (CPPS) who had not responded to conventional treatments, demonstrating its efficacy as a treatment option.

The therapy was safe, with no apparent side effects reported, and led to a notable reduction in the NIH Chronic Prostatitis Symptom Index scores, indicating a substantial improvement in patient symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback therapy for chronic pelvic pain syndrome. Ye, ZQ., Cai, D., Lan, RZ., et al.[2022]

In a pilot study involving 39 women with chronic pelvic pain, only about 10% of those screened (355 women) were randomized into the trial, indicating challenges in recruitment for clinical studies.

Direct mail and radio advertisements were the most effective recruitment methods, accounting for 38% and 34% of successful randomizations, respectively, but the effectiveness varied by site, suggesting that recruitment strategies may need to be tailored for different locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy. Cambron, JA., Hawk, C., Evans, R., et al.[2019]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

A brief Cognitive-Behavioral Therapy for Chronic Pain (CBT-CP) program consisting of 6 sessions significantly improved various symptoms in 77 primary care patients with chronic pain, demonstrating its effectiveness in a real-world setting.

The study found no significant differences in treatment outcomes between patients taking opioids and those not taking opioids, suggesting that the CBT-CP approach can be beneficial regardless of opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a 6-week Cognitive-Behavioral Therapy for Chronic Pain Group for veterans seen in primary care. Martinson, A., Craner, J., Clinton-Lont, J.[2021]

Cognitive Behavioral Therapy (CBT) is effective in addressing various factors that influence chronic low back pain (CLBP), but the term itself is too broad for future research, necessitating specific definitions based on the problems being addressed.

Despite its proven effectiveness, CBT is not widely implemented in clinical practice for CLBP, highlighting the need for early adoption and a public health approach to operationalize these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. Hanscom, DA., Brox, JI., Bunnage, R.[2020]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

References

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

Psychological therapies for chronic pelvic pain: systematic review of randomized controlled trials. [2018]

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

The Role of Trauma and Mental Health in the Treatment of Chronic Pelvic Pain: A Systematic Review of the Intervention Literature. [2021]

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

Clinical Review of Neuromusculoskeletal Complementary and Alternative Approaches for the Treatment of Chronic Pelvic Pain Syndrome. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Does evidence support physiotherapy management of adult female chronic pelvic pain? A systematic review. [2019]

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

Complementary and Alternative (CAM) Treatment Options for Women with Pelvic pain. [2022]

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

Effects of a Patient-Centered Graded Exposure Intervention Added to Manual Therapy for Women With Chronic Pelvic Pain: A Randomized Controlled Trial. [2019]

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

History of abuse and its relationship to pain experience and depression in women with chronic pelvic pain. [2021]

8. China pubmed.ncbi.nlm.nih.gov

Biofeedback therapy for chronic pelvic pain syndrome. [2022]

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

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Outcomes of a 6-week Cognitive-Behavioral Therapy for Chronic Pain Group for veterans seen in primary care. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Relationships between coping strategies and lumbar muscle activity in subjects with chronic low back pain. [2015]

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

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]