Pelvic Pain Education and Skills Training for Women Veterans

Pelvic Pain Education and Skills Training for Women Veterans - Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Distress, Emotional
• Intervention / Treatment: Behavioral: Brief ACT with CPP Education Treatment

Detailed 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 medical tests or procedures that might influence pain-related outcomes (e.g., surgical interventions, nerve block treatments)

Exclusion Criteria:

• Cognitive impairment
• Uncontrolled bipolar or psychotic diagnosis
• Active suicidal or homicidal ideation
• Receiving concurrent psychotherapy or who have received Acceptance and Commitment Therapy (ACT) within the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief ACT with CPP Education Group; 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.	Behavioral: Brief ACT with CPP Education Treatment; The Brief ACT with CPP Education treatment provides women veterans with new ways of responding to difficult thoughts and emotions related to pain while also encouraging them to engage in meaningful life activities. The CPP educational component includes information about pathology, risk factors, health outcomes, and treatment that are specific to women's biological and reproductive functioning. Treatment content has been further tailored to reflect the cultural experiences of women veterans (including discussions on the interplay between military culture, perceived social norms, and gender role expectations).; Other Names: Brief ACT for Pelvic Pain
No Intervention: Enhanced Treatment as Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Recruitment rates (number of women veterans enrolled/number who complete treatment)	Up to 1 year
Acceptability of intervention	Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)	3-month follow-up
Client Satisfaction Questionnaire (CSQ-8)	The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.	up to 8-weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change score in Pelvic Floor Distress Inventory (PFDI-20)	The 20 item PFDI-20 measures emotional distress related to pelvic pain symptoms. Scores range from 0-300. Higher scores indicate greater pelvic pain-related distress.	Change at 3-month follow-up from baseline
Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale	The 7 item BPI-SF, Pain Interference Scale measures level of pain interference in daily activities. Items are averaged to compute a mean scale score that ranges from 0 to 10. Higher scores indicate greater interference with daily activities.	Change at 3-month follow-up from baseline
Mean change in Numeric Rating Scale (NRS)	This single item will measure worst pain severity in past 7 days. Scores range from 0-10. Higher scores indicate greater pain severity.	Change at 3-month follow-up from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)	The 20 item CPAQ-revised is designed to measure acceptance of pain, which is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. Scores range from 0-120 with higher scores reflecting greater pain acceptance.	Change at 3-month follow-up from baseline
Mean change in Chronic Pain Values Inventory (CPVI)	The 12 item CPVI measures which values are important to an individual and the degree of success they are having in following their values. Two average scores are created (mean success and mean discrepancy ratings) that range from 0-5. Higher mean scores reflect greater success or greater discrepancy between importance of value and success of achieving it.	Change at 3-month follow-up from baseline

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Primary Care; Pain management; Women Veterans
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: H-53941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No