Pelvic Pain Education and Skills Training for Women Veterans

Pelvic Pain Clinical Trial

Official title:

Pelvic Pain Education and Skills Training for Women Veterans - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062043
• Other study ID #: H-53941
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: Derrecka M Boykin, Ph.D.
• Phone: 713-440-4603
• Email: Derrecka.Boykin[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional
• Pelvic Pain

Intervention

Behavioral:
• Brief ACT with CPP Education Treatment
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).

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)	The 20 item CPAQ-revised is designed to measure acceptance of pain, which is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. Scores range from 0-120 with higher scores reflecting greater pain acceptance.	Change at 3-month follow-up from baseline
Other	Mean change in Chronic Pain Values Inventory (CPVI)	The 12 item CPVI measures which values are important to an individual and the degree of success they are having in following their values. Two average scores are created (mean success and mean discrepancy ratings) that range from 0-5. Higher mean scores reflect greater success or greater discrepancy between importance of value and success of achieving it.	Change at 3-month follow-up from baseline
Primary	Feasibility of recruitment	Recruitment rates (number of women veterans enrolled/number who complete treatment)	Up to 1 year
Primary	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
Primary	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	Mean change score in Pelvic Floor Distress Inventory (PFDI-20)	The 20 item PFDI-20 measures emotional distress related to pelvic pain symptoms. Scores range from 0-300. Higher scores indicate greater pelvic pain-related distress.	Change at 3-month follow-up from baseline
Secondary	Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale	The 7 item BPI-SF, Pain Interference Scale measures level of pain interference in daily activities. Items are averaged to compute a mean scale score that ranges from 0 to 10. Higher scores indicate greater interference with daily activities.	Change at 3-month follow-up from baseline
Secondary	Mean change in Numeric Rating Scale (NRS)	This single item will measure worst pain severity in past 7 days. Scores range from 0-10. Higher scores indicate greater pain severity.	Change at 3-month follow-up from baseline