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Completed

NCT Number: NCT06062043

Pelvic Pain Education and Skills Training for Women Veterans

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.

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Key information

Conditions

Pelvic Pain Agnosia Distress, Emotional Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief ACT with CPP Education Treatment

Behavioral

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

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Up to 1 year

    Recruitment rates (number of women veterans enrolled/number who complete treatment)

  2. Acceptability of intervention

    Time frame: 3-month follow-up

    Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)

  3. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: up to 8-weeks from baseline

    The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.

Secondary outcomes

  1. Mean change score in Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: Change at 3-month follow-up from baseline

    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.

  2. Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale

    Time frame: Change at 3-month follow-up from baseline

    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.

  3. Mean change in Numeric Rating Scale (NRS)

    Time frame: Change at 3-month follow-up from baseline

    This single item will measure worst pain severity in past 7 days. Scores range from 0-10. Higher scores indicate greater pain severity.

Other outcomes

  1. Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)

    Time frame: Change at 3-month follow-up from baseline

    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.

  2. Mean change in Chronic Pain Values Inventory (CPVI)

    Time frame: Change at 3-month follow-up from baseline

    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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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