Clinical trial NCT04104542: MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
Official title: MOCHI: A Randomized Controlled Trial of Mindfulness as a Treatment for Chronic Pelvic Pain in Active Duty Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain
Depression
Inflammation Pelvic
Keywords: military
chronic pelvic pain
inflammation
mindfulness
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 41
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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?

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

Primary outcomes:
measure: Brief Pain Inventory Questionnaire measuring participants pelvic pain
timeFrame: pre- and at the end of the intervention (6 weeks)
Secondary outcomes:
measure: Five Facets of Mindfulness Questionnaire measuring mindfulness
timeFrame: pre- and at the end of the intervention (6 weeks)
measure: Patient Health Questionnaire -9 (PHQ-9) measuring depression
timeFrame: pre- and at the end of the intervention (6 weeks)
measure: 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
timeFrame: pre- and at the end of the intervention (6 weeks)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Univeristy of Missouri-Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Carol D Crisp, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
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.