Pelvic Pain Education and Skills Training for Women Veterans

Baylor College of Medicine

Status: Completed

Conditions: Pelvic Pain; Distress, Emotional

Treatments: Behavioral: Brief ACT with CPP Education Treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06062043

H-53941

Details and patient eligibility

About

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.

Full description

Chronic pelvic pain (CPP) is a debilitating pain condition that disproportionately affects women veterans (30% vs. 16% of nonveteran women vs. 3% of men). Pain intensity and disability are further exacerbated by psychosocial factors (such as depression, anxiety, posttraumatic distress) that may not be fully addressed through pharmacological and surgical interventions. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are identified as first-line nondrug treatments for pain conditions. Given the multifactorial nature of CPP, ACT may be of particular benefit to these patients as it provides a unified (transdiagnostic) approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Specifically, ACT targets core psychological and behavioral factors (e.g., avoidance) that underlie many psychiatric and medical conditions. Several meta-analyses show ACT is effective, even when compared to active interventions such as Cognitive-Behavioral Therapy.

In this pilot study, researchers will examine the feasibility and acceptability of conducting a larger randomized controlled trial to establish the efficacy of a brief ACT group treatment for women veterans experiencing pelvic pain. This pilot study builds on previous work adapting an empirically supported one-day ACT workshop to the specific needs of women veterans based on their feedback.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Brief ACT with CPP Education Group

Experimental group

Description:

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.

Treatment:

Behavioral: Brief ACT with CPP Education Treatment

Enhanced Treatment as Usual

No Intervention group

Description:

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.