MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women (AD)
Primary Purpose
Chronic Pelvic Pain, Depression, Inflammation Pelvic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Healthy Lifestyle
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pelvic Pain focused on measuring military, chronic pelvic pain, inflammation, mindfulness
Eligibility Criteria
Inclusion Criteria:
- 21-50 years of age
- 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:
- abdominal or pelvic surgery in last 6 months
- 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
Sites / Locations
- Univeristy of Missouri-Kansas City
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
Mindfulness MTHM
Mindfulness JBSA
Healthy Lifestyle MTHM
Healthy Lifestyle JBSA
Arm Description
online mindfulness based stress reduction training
online mindfulness based stress reduction training
online healthy lifestyle training
online healthy lifestyle training
Outcomes
Primary Outcome Measures
Brief Pain Inventory Questionnaire measuring participants pelvic pain
Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning. The participant rates their worst, least, average, and current pain intensity, lists current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI-sf is a modification of the Brief Pain Inventory - Long Form. Pelvic pain as measured by the Brief Pain Inventory questionnaire for each participant before the interventions and at 6 weeks. The BPIsf assesses severity of pain (4 items) and the impact of pain on daily function (7 items). Self-report Likert type scale measuring from no pain (0) to maximum pain (10).
Secondary Outcome Measures
Five Facets of Mindfulness Questionnaire measuring mindfulness
The Five Facets of Mindfulness questionnaire will be used to measure mindfulness for each participant before and at the end of the intervention. This scale has sub-scales that measure observing, describing, acting with awareness, and accepting without judgement which are combined for a total score. Self-report scale using 0=never/rare to 5=very often to always true for each question.
Patient Health Questionnaire -9 (PHQ-9) measuring depression
The PHQ-9 will be used to measure depression before and at the end of the interventions using a self-rated Likert type scale. The 9 item questionnaire asks participants to rate how often they experience depression and somatic complaints over the last 2 weeks. A consistent cut-off score for the PHQ-9 includes scores of 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe) depression.
Inflammation changes as measured in ng/ml of Interluekin-8, Interleukin 1ra, and Tumor Necrosis Factor-a pre- and post- intervention (6 weeks)/Physiologic parameter
Elisa's were used to measure changes in inflammation using ng/ml before and after interventions.
Full Information
NCT ID
NCT04104542
First Posted
May 1, 2019
Last Updated
July 9, 2022
Sponsor
University of Missouri, Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT04104542
Brief Title
MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
Acronym
AD
Official Title
MOCHI: A Randomized Controlled Trial of Mindfulness as a Treatment for Chronic Pelvic Pain in Active Duty Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
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
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 women's 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 (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.
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 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain, Depression, Inflammation Pelvic
Keywords
military, chronic pelvic pain, inflammation, mindfulness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness MTHM
Arm Type
Experimental
Arm Description
online mindfulness based stress reduction training
Arm Title
Mindfulness JBSA
Arm Type
Experimental
Arm Description
online mindfulness based stress reduction training
Arm Title
Healthy Lifestyle MTHM
Arm Type
Sham Comparator
Arm Description
online healthy lifestyle training
Arm Title
Healthy Lifestyle JBSA
Arm Type
Sham Comparator
Arm Description
online healthy lifestyle training
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Other Intervention Name(s)
MBSR
Intervention Description
on-line training on the website = www.palousemindfulness.com
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle
Other Intervention Name(s)
HL
Intervention Description
Diet and Exercise
Primary Outcome Measure Information:
Title
Brief Pain Inventory Questionnaire measuring participants pelvic pain
Description
Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning. The participant rates their worst, least, average, and current pain intensity, lists current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI-sf is a modification of the Brief Pain Inventory - Long Form. Pelvic pain as measured by the Brief Pain Inventory questionnaire for each participant before the interventions and at 6 weeks. The BPIsf assesses severity of pain (4 items) and the impact of pain on daily function (7 items). Self-report Likert type scale measuring from no pain (0) to maximum pain (10).
Time Frame
pre- and at the end of the intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Five Facets of Mindfulness Questionnaire measuring mindfulness
Description
The Five Facets of Mindfulness questionnaire will be used to measure mindfulness for each participant before and at the end of the intervention. This scale has sub-scales that measure observing, describing, acting with awareness, and accepting without judgement which are combined for a total score. Self-report scale using 0=never/rare to 5=very often to always true for each question.
Time Frame
pre- and at the end of the intervention (6 weeks)
Title
Patient Health Questionnaire -9 (PHQ-9) measuring depression
Description
The PHQ-9 will be used to measure depression before and at the end of the interventions using a self-rated Likert type scale. The 9 item questionnaire asks participants to rate how often they experience depression and somatic complaints over the last 2 weeks. A consistent cut-off score for the PHQ-9 includes scores of 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe) depression.
Time Frame
pre- and at the end of the intervention (6 weeks)
Title
Inflammation changes as measured in ng/ml of Interluekin-8, Interleukin 1ra, and Tumor Necrosis Factor-a pre- and post- intervention (6 weeks)/Physiologic parameter
Description
Elisa's were used to measure changes in inflammation using ng/ml before and after interventions.
Time Frame
pre- and at the end of the intervention (6 weeks)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Active Duty Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
21-50 years of age
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:
abdominal or pelvic surgery in last 6 months
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol D Crisp, PhD (c)
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Missouri-Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36251868
Citation
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.
Results Reference
derived
Learn more about this trial
MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
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