Clinical trial NCT06062043: Pelvic Pain Education and Skills Training for Women Veterans
Official title: Pelvic Pain Education and Skills Training for Women Veterans - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Distress, Emotional
Keywords: Acceptance and Commitment Therapy
Women Veterans
Primary Care
Pain management
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2023-10-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Up to 1 year
measure: Acceptability of intervention
timeFrame: 3-month follow-up
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: up to 8-weeks from baseline
Secondary outcomes:
measure: Mean change score in Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: Change at 3-month follow-up from baseline
measure: Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale
timeFrame: Change at 3-month follow-up from baseline
measure: Mean change in Numeric Rating Scale (NRS)
timeFrame: Change at 3-month follow-up from baseline
Other outcomes:
measure: Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)
timeFrame: Change at 3-month follow-up from baseline
measure: Mean change in Chronic Pain Values Inventory (CPVI)
timeFrame: Change at 3-month follow-up from baseline
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
References: