Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04104542
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2019-05-01
Brief Title:
MOCHI An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
Sponsor:
University of Missouri Kansas City
Organization:
University of Missouri Kansas City
Study Overview
Official Title:
MOCHI A Randomized Controlled Trial of Mindfulness as a Treatment for Chronic Pelvic Pain in Active Duty Women
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AD
Brief Summary:
Subject Population Active duty AD women with chronic pelvic pain CPP have different demands and stressors placed on them compared with their civilian counterparts Due to a decrease in functionality from pain not addressing these womens untreated CPP could be detrimental in readiness missions With limited studies on AD women with CPP or sufficient treatments available this study seeks to compare the effects on pain depression and inflammation in the mindfulness-based stress reduction MBSR group with a self-paced Healthy Lifestyle HL education control
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 n55 with a self-directed Healthy Lifestyle control n55
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
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 n55 with a self-directed Healthy Lifestyle control n55
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
Detailed Description:
The Purpose of this randomized controlled trial RCT is to compare the effects of an 8-week on-line MBSR training program with a HL self-directed education program control on pain depression and inflammation using questionnaires and biomarkers in AD women with CPP
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 womens 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 womens 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 womens inflammatory biomarkers
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 womens 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 womens 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 womens inflammatory biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None