Clinical trial NCT05368155: Chronic Pelvic Pain and Education Skills Training for Women Veterans
Official title: Chronic Pelvic Pain and Education Skills Training for Women Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Depression, Anxiety
Keywords: Acceptance and Commitment Therapy
Women Veterans
Primary Care
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Up to 1 year
measure: Acceptability of intervention
timeFrame: 2-month follow-up
Secondary outcomes:
measure: Mean change score in Patient Health Questionnaire (PHQ-9)
timeFrame: Change at 2-month follow-up from baseline
measure: Mean change score in Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Change at 2-month follow-up from baseline
measure: Mean change score in McGill Pain Questionnaire
timeFrame: Change at 2-month follow-up from baseline
measure: Mean change in Short Form Veteran Health Survey (VR-12)
timeFrame: Change at 2-month follow-up from baseline
Other outcomes:
measure: Mean change score in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)
timeFrame: Change at 2-month follow-up from baseline
measure: Mean change score in Chronic Pain Values Inventory (CPVI)
timeFrame: Change at 2-month follow-up from baseline
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
References: