What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) for Chronic Pelvic Pain Syndrome (CPPS) is generally well-tolerated with minimal side effects, primarily involving temporary emotional discomfort as patients confront distressing thoughts and feelings. Hormone-based medical therapies, such as progestin therapy, can cause side effects including weight gain, mood changes, and irregular bleeding. Surgical interventions, while effective for some, carry risks of complications such as infection, bowel dysfunction, and adhesions.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain conditions that can be relevant to Chronic Pelvic Pain Syndrome (CPPS). While specific FDA approvals for CPPS may not be detailed, treatments such as Cognitive Behavioral Therapy (CBT) have been widely recognized for their efficacy in altering pain perception and improving coping strategies. Additionally, pharmacologic treatments like antidepressants (SSRIs and SNRIs) and antiepileptic agents (gabapentin and pregabalin) have been approved for chronic pain management and may be used in CPPS. These treatments aim to reduce pain and improve quality of life by addressing both the physical and psychological aspects of chronic pain.

What other types of research exist?

Promising novel alternatives to CBT for CPPS patients include: 1) Mindfulness-Based Group Cognitive Behavior Therapy (M-gCBT), which integrates mindfulness techniques with CBT principles. 2) Hypnotic approaches, which have shown clinical implications for chronic pain management. 3) Acceptance and Commitment Therapy (ACT), particularly in online formats, which has demonstrated efficacy in chronic pain management. 4) Guided imagery and progressive muscle relaxation, which have been effective in reducing pain and distress in various chronic pain conditions.

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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Chronic Pelvic Pain Syndrome (EPPIC Trial)

N/A

Recruiting

Led By Jeffrey Lackner, PsyD

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MD-confirmed diagnosis of IC/BPS or CP/CPPS by study urologist or urogynecologist

Ability to understand and provide informed consent

Must not have

Presence of a neurological condition affecting the bladder (e.g., MS, Parkinson's disease, paraplegia)

The presence of a symptomatic urethral stricture (males only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve cognitive behavior therapy and patient education/support, there are no direct medical side effects; however, participants may experience emotional discomfort or increased awareness of their condition during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I understand the study and can give my consent.

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I have had moderate to severe pelvic pain for the past 3 months that affects my daily life.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am a male with a painful narrowing of the urethra.

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I have had bladder inflammation due to tuberculosis, radiation, or chemotherapy.

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My schedule prevents me from attending clinic sessions or practicing at home.

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I was diagnosed and treated for cancer in my pelvic area.

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I do not have major issues with thinking, seeing, or hearing.

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I cannot attend the screening visits.

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I cannot attend follow-up visits or undergo treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Global Impressions - Improvement Scale Patient Version (CGI-I)

Secondary study objectives

Brief Symptom Inventory (BSI 18)

Client Satisfaction Questionnaire (CSQ)

Genitourinary Pain Index (GUPI)

+3 more

Other study objectives

Beck Depression Inventory - II (BDI-II)

Change from baseline of the PROMIS - Sleep Disturbance SF-8b

PROMIS - Fatigue SF-7a

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Minimal Contact-Cognitive Behavior TherapyExperimental Treatment1 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/SupportActive Control1 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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) is a key treatment for Chronic Pelvic Pain Syndrome (CPPS) as it modifies pain perception and enhances coping strategies by addressing the cognitive and emotional dimensions of pain. This is particularly important for CPPS patients because it helps reduce pain catastrophizing and stress, thereby improving their overall mental health and pain management. Other treatments, such as physical therapy and mindfulness-based stress reduction (MBSR), complement CBT by improving physical function and reducing stress, respectively. These multimodal approaches are essential as CPPS involves both physical and psychological factors, necessitating comprehensive treatment strategies.

Effects of a Patient-Centered Graded Exposure Intervention Added to Manual Therapy for Women With Chronic Pelvic Pain: A Randomized Controlled Trial.Assessing psychological factors, social aspects and psychiatric co-morbidity associated with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men -- a systematic review.[Chronic pelvic pain in women].