NCT05368155

Chronic Pelvic Pain and Education Skills Training for Women Veterans

Completed NA Last updated 3 March 2023

What this trial tests

NA trial testing Brief ACT for Pelvic Pain in Pelvic Pain in 13 participants. Completed in 20 February 2023.

Timeline

15 September 2022

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	13
Start date	15 September 2022
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Brief ACT for Pelvic Pain

Conditions studied

• Pelvic Pain — all drugs for Pelvic Pain →
• Depression, Anxiety — all drugs for Depression, Anxiety →

Sponsor

Baylor College of Medicine

Who can join

18 and older, female only, with Pelvic Pain or Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.