Skip to main content
OpenTrials
Completed

NCT Number: NCT05368155

Chronic Pelvic Pain and Education Skills Training for Women Veterans

Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures).

Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA).

In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Pain Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being a Veteran
  • Being female
  • Having a diagnosis of chronic pelvic pain
  • Endorsing severe pain (score ≤ 7 on Brief Pain Inventory [BPI]) or moderate to severe pain plus clinically significant psychological distress (score ≤ 3 on BPI and score ≤ 10 on Patient Health Questionnaire-9 [PHQ-9] or Generalized Anxiety Disorder-7 [GAD-7])

Exclusion criteria

  • Cognitive impairment
  • An uncontrolled bipolar or psychotic diagnosis
  • Active suicidal ideation
  • Receiving concurrent psychotherapy or who have received ACT within the past year

Treatment and study plan

Brief ACT for Pelvic Pain

Behavioral

The Brief ACT for Pelvic Pain treatment will include three weekly, 90-minute group sessions that teach Veterans new ways to respond to difficult thoughts and emotions related to pain (Acceptance and Mindfulness Training) and encourage behavioral (re)engagement in meaningful life activities (Behavioral Change Training). The overall goal is to cultivate psychological flexibility by helping Veterans learn to respond to life events in ways which do not exacerbate difficulties or restrict engagement in meaningful activities. Workshop content is integrated with education on pelvic pain (its diagnostic criteria, etiology, and associated health outcomes) to increase alignment of the treatment with patient needs.

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Up to 1 year

    Recruitment rates (number enrolled/number who complete treatment)

  2. Acceptability of intervention

    Time frame: 2-month follow-up

    Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)

Secondary outcomes

  1. Mean change score in Patient Health Questionnaire (PHQ-9)

    Time frame: Change at 2-month follow-up from baseline

    The 9-item PHQ-9 measures severity of depressive symptoms. Scores range from 0-36 with higher scores reflecting greater symptom severity.

  2. Mean change score in Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Change at 2-month follow-up from baseline

    The 7-item GAD-7 measures severity of anxiety symptoms. Scores range from 0-28 with higher scores reflecting greater symptom severity.

  3. Mean change score in McGill Pain Questionnaire

    Time frame: Change at 2-month follow-up from baseline

    The McGill Pain Questionnaire assesses pain intensity and type. Scores range from 0-100 with higher scores reflecting greater pain severity.

  4. Mean change in Short Form Veteran Health Survey (VR-12)

    Time frame: Change at 2-month follow-up from baseline

    The VR-12 is a short-form measures self-reported health and functioning. Higher scaled scores indicate greater functional impairment.

Other outcomes

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

    Time frame: Change at 2-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 score in Chronic Pain Values Inventory (CPVI)

    Time frame: Change at 2-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 in achieving it.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2022
Registry last updated
Mar 3, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.