Pelvic Pain Education and Skills Training for Women Veterans

Last updated: January 27, 2025
Sponsor: Baylor College of Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Treatment

Brief ACT with CPP Education Treatment

Clinical Study ID

NCT06062043
H-53941
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Served in US Armed Forces

  • Self-identify as female/woman

  • Have a diagnosis of chronic pelvic pain (CPP)

  • Endorse moderate to severe pain (worst pain score ≥ 4 on Numeric Rating Scale [NRS])AND pain-related distress (score ≥ 80 on Pelvic Floor Distress Inventory [PFDI-20])

  • Be stable on mood and pain medication for four weeks and not scheduled for medicaltests or procedures that might influence pain-related outcomes (e.g., surgicalinterventions, nerve block treatments)

Exclusion

Exclusion Criteria:

  • Cognitive impairment

  • Uncontrolled bipolar or psychotic diagnosis

  • Active suicidal or homicidal ideation

  • Receiving concurrent psychotherapy or who have received Acceptance and CommitmentTherapy (ACT) within the past year

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Brief ACT with CPP Education Treatment
Phase:
Study Start date:
March 04, 2024
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Michael E. DeBakey VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

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