Chronic Pelvic Pain and Education Skills Training for Women Veterans

Not Applicable

Completed

• Conditions: Pelvic Pain; Depression, Anxiety
• Interventions: Behavioral: Brief ACT for Pelvic Pain

• Registration Number: NCT05368155
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-10
• Study Start: 2022-09-15
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT and Education Group	Brief ACT for Pelvic Pain	The Acceptance and Commitment Training (ACT) and education group will receive the Brief ACT for Pelvic Pain treatment, which will include three weekly, 90-minute group sessions.

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention	2-month follow-up	Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)
Feasibility of recruitment	Up to 1 year	Recruitment rates (number enrolled/number who complete treatment)

Secondary Outcome Measures

Name	Time	Method
Mean change score in McGill Pain Questionnaire	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.
Mean change score in Patient Health Questionnaire (PHQ-9)	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.
Mean change score in Generalized Anxiety Disorder Scale (GAD-7)	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.
Mean change in Short Form Veteran Health Survey (VR-12)	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.

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States