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Behavioral Intervention

Pelvic Pain Education and Skills Training for Pelvic Pain

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-identify as female/woman
Have a diagnosis of chronic pelvic pain (CPP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will test a treatment for women veterans with pelvic pain to see if it is successful and acceptable.

Who is the study for?
This trial is for US women veterans with chronic pelvic pain who have stable mood and pain medication use, and experience moderate to severe pain and distress. They must not be undergoing other treatments that could affect their pain, nor have cognitive impairments or uncontrolled bipolar/psychotic disorders.Check my eligibility
What is being tested?
The study tests a brief Acceptance and Commitment Training (ACT) group intervention against usual care for managing pelvic pain in women veterans. Participants will complete surveys and some will do phone interviews to assess the effectiveness of ACT.See study design
What are the potential side effects?
Since this trial focuses on education and skills training rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing painful experiences during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I identify as a female.
Select...
I have been diagnosed with chronic pelvic pain.
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I experience severe pain and distress due to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of intervention
Client Satisfaction Questionnaire (CSQ-8)
Feasibility of recruitment
Secondary outcome measures
Mean change in Numeric Rating Scale (NRS)
Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale
Mean change score in Pelvic Floor Distress Inventory (PFDI-20)
Other outcome measures
Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)
Mean change in Chronic Pain Values Inventory (CPVI)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brief ACT with CPP Education GroupExperimental Treatment1 Intervention
The Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education Group will attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities.
Group II: Enhanced Treatment as UsualActive Control1 Intervention
The enhanced treatment as usual (TAU) condition will receive a letter with CPP-specific treatment resources and encouraged to consult with their VHA primary care clinicians for additional education and treatment options.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,392 Total Patients Enrolled
2 Trials studying Pelvic Pain
59 Patients Enrolled for Pelvic Pain
US Department of Veterans AffairsFED
869 Previous Clinical Trials
495,923 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for participants in this study?

"Clinicaltrials.gov shows that this clinical trial, initially posted on October 1st 2023 and updated most recently on September 25th 2023, is no longer enrolling patients. Nonetheless, 84 other studies are actively seeking participants at the moment."

Answered by AI
~13 spots leftby Sep 2024