Chronic Pelvic Pain and Education Skills Training for Women Veterans

NCT05368155 | Completed

• 1 other identifier: H-51197
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Depression, Anxiety

Keywords

Acceptance and Commitment Therapy; Women Veterans; Primary Care

Outcome Measures

Primary Outcomes (2)

• Feasibility of recruitment

  Recruitment rates (number enrolled/number who complete treatment)

  Up to 1 year

• Acceptability of intervention

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

  2-month follow-up

Secondary Outcomes (4)

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

  Change at 2-month follow-up from baseline

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

  Change at 2-month follow-up from baseline

• Mean change score in McGill Pain Questionnaire

  Change at 2-month follow-up from baseline

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

  Change at 2-month follow-up from baseline

Other Outcomes (2)

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

  Change at 2-month follow-up from baseline

• Mean change score in Chronic Pain Values Inventory (CPVI)

  Change at 2-month follow-up from baseline

Study Arms (2)

ACT and Education Group

EXPERIMENTAL

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.

Behavioral: Brief ACT for Pelvic Pain

Enhanced Treatment As Usual

NO INTERVENTION

The Enhanced treatment as usual (TAU) condition will receive a letter with treatment resources and encouraged to consult with their VHA primary care clinicians for additional education and treatment options.

Interventions

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.

ACT and Education Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only participants who identify as "female" can take part in this study. The intervention is specifically designed for women veterans who experience chronic pelvic pain.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[GAD-7\])

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pelvic Pain; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 10, 2022
• Study Start: September 15, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (1)