MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
NCT ID: NCT04104542
Last Updated: 2022-07-12
Study Results
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Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2019-06-01
2019-10-31
Brief Summary
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Research Design: This randomized controlled trial will compare depression, pain, and biomarkers known for inflammation and pain in AD women with CPP pre-post an 8-week MBSR online intervention (n=55) with a self-directed Healthy Lifestyle control (n=55).
Instruments: All participants will complete a demographic worksheet, Five Facets of Mindfulness Questionnaire (FFQ), a brief pain inventory (BPI), and a Patient Health Questionnaire (PHQ-9) pre-post intervention (MBSR or HL).
Procedure: Participants will have 8-weeks of online training with voice-over slides in RedCap. The primary investigator will contact participants weekly for both groups and review diaries to help monitor fidelity and guide progress. Blood will be drawn for biomarkers for inflammation and pain and questionnaires will be completed pre-post intervention.
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Detailed Description
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Specific Aims and Research Questions It is important to understand predictors of CPP among women in active military service and test strategies that may mitigate the negative impact of CPP. The long-term goal of this research is to identify a non-invasive, easy to learn, alternative method that can successfully assist active duty women with CPP to regulate daily perceptions of their body, improve pain management skills to better cope, and ultimately improve functionality and QOL.
Specific Aim #1: To compare the depression of active duty (AD) women with CPP pre-post an 8-week online MBSR program with an 8-week Healthy Lifestyle (HL) nutrition self-paced education.
Hypothesis #1: AD women with CPP in an 8-week MBSR Program will have an overall decreased depression pre-post as compared to the HL control.
Question #1: What is the effect of an online MBSR training program as compared to a HL control pre-post on AD women's depression scores? Specific Aim #2: To compare the perception of pain in AD women with CPP pre-post an 8-week online MBSR program with an 8-week HL control.
Hypothesis 2: AD women with CPP in an 8-week MBSR Program will have overall decreased perception of pain pre-post as compared to the HL control.
Question #2: What is the effect of an online MBSR training program as compared to a HL control pre-post on AD women's perception of pain? Specific Aim #3: Compare the inflammatory biomarkers and miRNAs changes in AD women with CPP pre-post an 8-week online MBSR program with an 8-week HL control.
Hypothesis #3: AD women with CPP in an 8-week MBSR training program will demonstrate an overall decrease in inflammation as demonstrated by the biomarker changes pre-post.
Question #3: What is the effect of an online MBSR training program as compared to a HL control pre-post on active duty women's inflammatory biomarkers?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Mindfulness MTHM
online mindfulness based stress reduction training
Mindfulness based stress reduction
on-line training on the website = www.palousemindfulness.com
Mindfulness JBSA
online mindfulness based stress reduction training
Mindfulness based stress reduction
on-line training on the website = www.palousemindfulness.com
Healthy Lifestyle MTHM
online healthy lifestyle training
Healthy Lifestyle
Diet and Exercise
Healthy Lifestyle JBSA
online healthy lifestyle training
Healthy Lifestyle
Diet and Exercise
Interventions
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Mindfulness based stress reduction
on-line training on the website = www.palousemindfulness.com
Healthy Lifestyle
Diet and Exercise
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* active duty female
* English as first language
* diagnosed with chronic pelvic pain
* Has access to a computer, telephone, and wifi
* Will not PCS or deploy in the next 3 months without access to computer
* consent form signed
Exclusion Criteria
* known vaginal or pelvic infection at the time of study enrollment, not currently being treated
* menopausal
* pregnant
* breastfeeding
* underlying disease including: diabetes, tumors, auto-immune disorders
21 Years
50 Years
FEMALE
Yes
Sponsors
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University of Missouri, Kansas City
OTHER
Responsible Party
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Carol Crisp
Principal Investigator
Principal Investigators
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Carol D Crisp, PhD (c)
Role: PRINCIPAL_INVESTIGATOR
University of Missouri, Kansas City
Locations
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Univeristy of Missouri-Kansas City
Kansas City, Missouri, United States
Countries
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References
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Crisp CD, Baldi R, Fuller M, Abreu E, Nackley AG. Complementary Approaches for Military Women with Chronic Pelvic Pain: A Randomized Trial. J Integr Complement Med. 2023 Jan;29(1):22-30. doi: 10.1089/jicm.2022.0616. Epub 2022 Oct 12.
Other Identifiers
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18-078
Identifier Type: -
Identifier Source: org_study_id
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