Pelvic Pain Education & Skills Training for Women Veterans

Status Recruiting

Clinical Trial Summary

The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial. Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition). Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.

Clinical Trial Description

Chronic pelvic pain (CPP) is a debilitating pain condition that disproportionately affects women veterans (30% vs. 16% of nonveteran women vs. 3% of men). Pain intensity and disability are further exacerbated by psychosocial factors (such as depression, anxiety, posttraumatic distress) that may not be fully addressed through pharmacological and surgical interventions. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are identified as first-line nondrug treatments for pain conditions. Given the multifactorial nature of CPP, ACT may be of particular benefit to these patients as it provides a unified (transdiagnostic) approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Specifically, ACT targets core psychological and behavioral factors (e.g., avoidance) that underlie many psychiatric and medical conditions. Several meta-analyses show ACT is effective, even when compared to active interventions such as Cognitive-Behavioral Therapy. In this pilot study, researchers will examine the feasibility and acceptability of conducting a larger randomized controlled trial to establish the efficacy of a brief ACT group treatment for women veterans experiencing pelvic pain. This pilot study builds on previous work adapting an empirically supported one-day ACT workshop to the specific needs of women veterans based on their feedback. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06062043
Study type	Interventional
Source	Baylor College of Medicine
Contact	Derrecka M Boykin, Ph.D.
Phone	713-440-4603
Email	Derrecka.Boykin@va.gov
Status	Recruiting
Phase	N/A
Start date	March 4, 2024
Completion date	February 28, 2025

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See also
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Completed	`NCT05368155` - Chronic Pelvic Pain and Education Skills Training for Women Veterans	N/A
Completed	`NCT04179149` - Enriched Environments in Endometriosis	N/A
Not yet recruiting	`NCT05530681` - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth	N/A
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Completed	`NCT03715777` - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain	Phase 3
Recruiting	`NCT05926752` - Photobiomodulation for Myofascial Pelvic Pain	N/A
Completed	`NCT02588885` - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention	N/A
Completed	`NCT02261740` - Program to Overcome Pelvic Pain With Yoga	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pelvic Pain Education and Skills Training for Women Veterans

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms