Pelvic Pain Education and Skills Training for Women Veterans

NCT06062043 | Completed

• 1 other identifier: H-53941
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial. Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition). Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.

Conditions

Pelvic Pain; Distress, Emotional

Keywords

Acceptance and Commitment Therapy; Women Veterans; Primary Care; Pain management

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment

  Recruitment rates (number of women veterans enrolled/number who complete treatment)

  Up to 1 year

• Acceptability of intervention

  Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)

  3-month follow-up

• Client Satisfaction Questionnaire (CSQ-8)

  The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.

  up to 8-weeks from baseline

Secondary Outcomes (3)

• Mean change score in Pelvic Floor Distress Inventory (PFDI-20)

  Change at 3-month follow-up from baseline

• Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale

  Change at 3-month follow-up from baseline

• Mean change in Numeric Rating Scale (NRS)

  Change at 3-month follow-up from baseline

Other Outcomes (2)

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

  Change at 3-month follow-up from baseline

• Mean change in Chronic Pain Values Inventory (CPVI)

  Change at 3-month follow-up from baseline

Study Arms (2)

Brief ACT with CPP Education Group

EXPERIMENTAL

The Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education Group will attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities.

Behavioral: Brief ACT with CPP Education Treatment

Enhanced Treatment as Usual

NO INTERVENTION

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

Interventions

Brief ACT with CPP Education Treatment BEHAVIORAL

The Brief ACT with CPP Education treatment provides women veterans with new ways of responding to difficult thoughts and emotions related to pain while also encouraging them to engage in meaningful life activities. The CPP educational component includes information about pathology, risk factors, health outcomes, and treatment that are specific to women's biological and reproductive functioning. Treatment content has been further tailored to reflect the cultural experiences of women veterans (including discussions on the interplay between military culture, perceived social norms, and gender role expectations).

Also known as: Brief ACT for Pelvic Pain

Brief ACT with CPP Education Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is intended for veterans who self-identify as female/woman.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Served in US Armed Forces
• Self-identify as female/woman
• Have a diagnosis of chronic pelvic pain (CPP)
• Endorse moderate to severe pain (worst pain score ≥ 4 on Numeric Rating Scale \[NRS\]) AND pain-related distress (score ≥ 80 on Pelvic Floor Distress Inventory \[PFDI-20\])
• Be stable on mood and pain medication for four weeks and not scheduled for medical tests or procedures that might influence pain-related outcomes (e.g., surgical interventions, nerve block treatments)

You may not qualify if:

• Cognitive impairment
• Uncontrolled bipolar or psychotic diagnosis
• Active suicidal or homicidal ideation
• Receiving concurrent psychotherapy or who have received Acceptance and Commitment Therapy (ACT) within the past year

Sponsors & Collaborators

• Baylor College of Medicine: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pelvic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors will be blinded to randomization assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 2, 2023
• Study Start: March 4, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)