MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
Condition: Chronic Pelvic Pain; Depression; Inflammation Pelvic
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Inflammation; Pelvic Pain
Study type: Interventional

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?
    

Intervention name(s): Mindfulness based stress reduction; Healthy Lifestyle
Intervention type(s): Behavioral; Behavioral
Intervention description(s): on-line training on the website = www.palousemindfulness.com; Diet and Exercise
Other intervention name(s): MBSR; HL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: military; chronic pelvic pain; inflammation; mindfulness