Cognitive Behavioral Therapy for Chronic Pelvic Pain Syndrome

(EPPIC Trial)

Recruiting at 3 trial locations

Overseen By Patricia O'Leary, EdM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 10 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, short version of cognitive behavioral therapy (CBT) to help individuals with chronic pelvic pain syndrome improve their well-being. CBT teaches ways to manage pain and other symptoms affecting daily life. The study compares this therapy to educational support to determine which is more effective. Individuals who have experienced moderate pelvic pain for at least six months, impacting their daily activities, might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative therapy options that could significantly enhance quality of life.

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 prior data suggests that this cognitive behavioral therapy is safe for treating chronic pelvic pain syndrome?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for treating long-term pain, including chronic pelvic pain. CBT helps individuals manage pain using practical techniques. Studies have found that CBT can effectively address chronic pain without causing major side effects.

One study demonstrated that combining CBT with regular care reduced pain and improved function over time. Another study confirmed that CBT is effective for chronic pain and is generally safe, with most individuals tolerating it well and few reports of serious problems.

Overall, Minimal Contact-Cognitive Behavior Therapy (MC-CBT) appears to be a safe choice for those with chronic pelvic pain. It focuses on teaching skills to manage pain and improve quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Minimal Contact-Cognitive Behavior Therapy for chronic pelvic pain syndrome because it offers a fresh approach by focusing on teaching patients practical self-management tools. Unlike typical treatments that often rely on medication to relieve pain and urinary symptoms, this therapy targets the biobehavioral factors that can worsen these symptoms. This method empowers patients to actively manage their condition, potentially leading to long-term relief without the side effects associated with standard pharmaceutical options.

What evidence suggests that this trial's treatments could be effective for chronic pelvic pain syndrome?

Research shows that Cognitive Behavioral Therapy (CBT) effectively treats chronic pelvic pain, including urologic chronic pain syndrome (UCPPS). In this trial, participants may receive Minimal Contact-Cognitive Behavior Therapy, which teaches practical tools and strategies for self-care to manage pain. Strong evidence supports CBT, with over 20 reviews and analyses confirming its benefits for chronic pain. Although the exact mechanisms remain unclear, patients often experience reduced pain and fewer related symptoms. Overall, CBT focuses on the interaction between the body and mind in worsening pelvic pain, making it a promising option for many. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey Lackner, PsyD

Principal Investigator

University at Buffalo (SUNY)

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Minimal Contact-Cognitive Behavior Therapy
• Patient Education/Support

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.

How Is the Trial Designed?

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

Minimal Contact-Cognitive Behavior Therapy is already approved in United States for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic Pelvic Pain Syndrome
• Urologic Chronic Pelvic Pain Syndrome (UCPPS)
• Interstitial Cystitis/Bladder Pain Syndrome
• Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

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]

A 6-week intervention combining patient-centered graded exposure therapy with manual therapy significantly improved fear-avoidance behavior and physical functioning in women with chronic pelvic pain, compared to manual therapy alone.

The study involved 49 women and showed that the combined approach not only provided immediate benefits but also maintained improvements in outcomes at a 3-month follow-up, highlighting its long-term efficacy.

NCBI (Pubmed)

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. Ariza-Mateos, MJ., Cabrera-Martos, I., Ortiz-Rubio, A., 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]

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]

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]

In a study of 63 individuals with chronic low back pain (CLBP), the coping strategy of 'catastrophizing' was linked to increased lumbar muscle activity, suggesting it may contribute to pain persistence.

Conversely, the coping strategy of 'distraction' was associated with greater lumbar muscle relaxation, indicating it may help reduce muscle tension during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between coping strategies and lumbar muscle activity in subjects with chronic low back pain. van der Hulst, M., Vollenbroek-Hutten, MM., Schreurs, KM., et al.[2015]

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]

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]

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]

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]

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]

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]

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]

Citations

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Cognitive Behavioral Therapy for Chronic Pelvic Pain - PubMed Results: While evidence supports CBT for treatment-refractory chronic pain disorders, there is limited understanding of why or how CBT might work, for whom it ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06554-9

Study protocol and methods for Easing Pelvic Pain ... A clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521689620300707

Cognitive behavioral therapy for the treatment of chronic ... Evidence suggests CBT is beneficial in treating chronic pelvic pain (CPP) patients · Treating the underlying etiology of the CPP is beneficial and may have an ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003847

Cognitive Behavioral Therapy for Chronic Pelvic Pain Empirical support for CBT as a self-management treatment for chronic pain is based on well over 20 systematic reviews. Meta-analyses generally ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8671982/

results of a non-randomised controlled feasibility trial - PMC Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023000603

Barriers and Facilitators of Evidence-Based ... EBPs with demonstrated effectiveness for improving chronic pain outcomes include cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2022/12090/non_pharmacological_therapies_for_treating_chronic.8.aspx

Non-pharmacological therapies for treating chronic pelvic... A 1-year follow-up study indicated that CBT combined with gynecologic care could reduce psychological symptoms, pain, and related dysfunction in ...

8. researchgate.net researchgate.net/publication/343526691_Cognitive_Behavioral_Therapy_for_the_Treatment_of_Chronic_Pelvic_Pain

Cognitive Behavioral Therapy for the Treatment of Chronic ... [7] Cognitive behavioral therapy (CBT), a psychotherapy for CPP in women, is effective and widely used in treating chronic pain conditions (SOGC ...