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Chronic Pelvic Pain and Education Skills Training for Women Veterans

Primary Purpose

Pelvic Pain, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief ACT for Pelvic Pain
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

Eligibility Criteria

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

Inclusion Criteria:

  • Being a Veteran
  • Being female
  • Having a diagnosis of chronic pelvic pain
  • Endorsing severe pain (score ≤ 7 on Brief Pain Inventory [BPI]) or moderate to severe pain plus clinically significant psychological distress (score ≤ 3 on BPI and score ≤ 10 on Patient Health Questionnaire-9 [PHQ-9] or Generalized Anxiety Disorder-7 [GAD-7])

Exclusion Criteria:

  • Cognitive impairment
  • An uncontrolled bipolar or psychotic diagnosis
  • Active suicidal ideation
  • Receiving concurrent psychotherapy or who have received 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

ACT and Education Group

Enhanced Treatment As Usual

Arm Description

The Acceptance and Commitment Training (ACT) and education group will receive the Brief ACT for Pelvic Pain treatment, which will include three weekly, 90-minute group sessions.

The Enhanced treatment as usual (TAU) condition will receive a letter with 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 enrolled/number who complete treatment)
Acceptability of intervention
Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)

Secondary Outcome Measures

Mean change score in Patient Health Questionnaire (PHQ-9)
The 9-item PHQ-9 measures severity of depressive symptoms. Scores range from 0-36 with higher scores reflecting greater symptom severity.
Mean change score in Generalized Anxiety Disorder Scale (GAD-7)
The 7-item GAD-7 measures severity of anxiety symptoms. Scores range from 0-28 with higher scores reflecting greater symptom severity.
Mean change score in McGill Pain Questionnaire
The McGill Pain Questionnaire assesses pain intensity and type. Scores range from 0-100 with higher scores reflecting greater pain severity.
Mean change in Short Form Veteran Health Survey (VR-12)
The VR-12 is a short-form measures self-reported health and functioning. Higher scaled scores indicate greater functional impairment.

Full Information

First Posted
May 3, 2022
Last Updated
March 1, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05368155
Brief Title
Chronic Pelvic Pain and Education Skills Training for Women Veterans
Official Title
Chronic Pelvic Pain and Education Skills Training for Women Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

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
Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures). Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA). In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT and Education Group
Arm Type
Experimental
Arm Description
The Acceptance and Commitment Training (ACT) and education group will receive the Brief ACT for Pelvic Pain treatment, which will include three weekly, 90-minute group sessions.
Arm Title
Enhanced Treatment As Usual
Arm Type
No Intervention
Arm Description
The Enhanced treatment as usual (TAU) condition will receive a letter with 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 for Pelvic Pain
Intervention Description
The Brief ACT for Pelvic Pain treatment will include three weekly, 90-minute group sessions that teach Veterans new ways to respond to difficult thoughts and emotions related to pain (Acceptance and Mindfulness Training) and encourage behavioral (re)engagement in meaningful life activities (Behavioral Change Training). The overall goal is to cultivate psychological flexibility by helping Veterans learn to respond to life events in ways which do not exacerbate difficulties or restrict engagement in meaningful activities. Workshop content is integrated with education on pelvic pain (its diagnostic criteria, etiology, and associated health outcomes) to increase alignment of the treatment with patient needs.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Recruitment rates (number enrolled/number who complete treatment)
Time Frame
Up to 1 year
Title
Acceptability of intervention
Description
Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)
Time Frame
2-month follow-up
Secondary Outcome Measure Information:
Title
Mean change score in Patient Health Questionnaire (PHQ-9)
Description
The 9-item PHQ-9 measures severity of depressive symptoms. Scores range from 0-36 with higher scores reflecting greater symptom severity.
Time Frame
Change at 2-month follow-up from baseline
Title
Mean change score in Generalized Anxiety Disorder Scale (GAD-7)
Description
The 7-item GAD-7 measures severity of anxiety symptoms. Scores range from 0-28 with higher scores reflecting greater symptom severity.
Time Frame
Change at 2-month follow-up from baseline
Title
Mean change score in McGill Pain Questionnaire
Description
The McGill Pain Questionnaire assesses pain intensity and type. Scores range from 0-100 with higher scores reflecting greater pain severity.
Time Frame
Change at 2-month follow-up from baseline
Title
Mean change in Short Form Veteran Health Survey (VR-12)
Description
The VR-12 is a short-form measures self-reported health and functioning. Higher scaled scores indicate greater functional impairment.
Time Frame
Change at 2-month follow-up from baseline
Other Pre-specified Outcome Measures:
Title
Mean change score 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 2-month follow-up from baseline
Title
Mean change score 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 in achieving it.
Time Frame
Change at 2-month follow-up from baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only participants who identify as "female" can take part in this study. The intervention is specifically designed for women veterans who experience chronic pelvic pain.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a Veteran Being female Having a diagnosis of chronic pelvic pain Endorsing severe pain (score ≤ 7 on Brief Pain Inventory [BPI]) or moderate to severe pain plus clinically significant psychological distress (score ≤ 3 on BPI and score ≤ 10 on Patient Health Questionnaire-9 [PHQ-9] or Generalized Anxiety Disorder-7 [GAD-7]) Exclusion Criteria: Cognitive impairment An uncontrolled bipolar or psychotic diagnosis Active suicidal ideation Receiving concurrent psychotherapy or who have received ACT within the past year
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

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Chronic Pelvic Pain and Education Skills Training for Women Veterans

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