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Pelvic Pain Education and Skills Training for Women Veterans

Primary Purpose

Pelvic Pain, Distress, Emotional

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief ACT with CPP Education Treatment
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Acceptance and Commitment Therapy, Women Veterans, Primary Care, Pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Michael E. DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief ACT with CPP Education Group

Enhanced Treatment as Usual

Arm 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.

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.

Outcomes

Primary Outcome Measures

Feasibility of recruitment
Recruitment rates (number of women veterans enrolled/number who complete treatment)
Acceptability of intervention
Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 12, 2023
Last Updated
October 2, 2023
Sponsor
Baylor College of Medicine
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT06062043
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Distress, Emotional
Keywords
Acceptance and Commitment Therapy, Women Veterans, Primary Care, Pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcomes assessors will be blinded to randomization assignments.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief ACT with CPP Education Group
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Treatment as Usual
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Brief ACT with CPP Education Treatment
Other Intervention Name(s)
Brief ACT for Pelvic Pain
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Recruitment rates (number of women veterans enrolled/number who complete treatment)
Time Frame
Up to 1 year
Title
Acceptability of intervention
Description
Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)
Time Frame
3-month follow-up
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.
Time Frame
up to 8-weeks from baseline
Secondary Outcome Measure Information:
Title
Mean change score in Pelvic Floor Distress Inventory (PFDI-20)
Description
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.
Time Frame
Change at 3-month follow-up from baseline
Title
Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale
Description
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.
Time Frame
Change at 3-month follow-up from baseline
Title
Mean change in Numeric Rating Scale (NRS)
Description
This single item will measure worst pain severity in past 7 days. Scores range from 0-10. Higher scores indicate greater pain severity.
Time Frame
Change at 3-month follow-up from baseline
Other Pre-specified Outcome Measures:
Title
Mean change in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)
Description
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.
Time Frame
Change at 3-month follow-up from baseline
Title
Mean change in Chronic Pain Values Inventory (CPVI)
Description
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.
Time Frame
Change at 3-month follow-up from baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is intended for veterans who self-identify as female/woman.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derrecka M Boykin, Ph.D.
Phone
713-440-4603
Email
Derrecka.Boykin@va.gov
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pelvic Pain Education and Skills Training for Women Veterans

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