MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women

Study Overview
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Brief Summary
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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
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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?

Official Title
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MOCHI: A Randomized Controlled Trial of Mindfulness as a Treatment for Chronic Pelvic Pain in Active Duty Women

Conditions
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Chronic Pelvic Pain, Depression, Inflammation Pelvic

Intervention / Treatment
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* Behavioral: Mindfulness based stress reduction
* Behavioral: Healthy Lifestyle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness MTHM<br>online mindfulness based stress reduction training | Behavioral: Mindfulness based stress reduction<br>* on-line training on the website = www.palousemindfulness.com<br>* Other names: MBSR;|
| Experimental: Mindfulness JBSA<br>online mindfulness based stress reduction training | Behavioral: Mindfulness based stress reduction<br>* on-line training on the website = www.palousemindfulness.com<br>* Other names: MBSR;|
| Sham Comparator: Healthy Lifestyle MTHM<br>online healthy lifestyle training | Behavioral: Healthy Lifestyle<br>* Diet and Exercise<br>* Other names: HL;|
| Sham Comparator: Healthy Lifestyle JBSA<br>online healthy lifestyle training | Behavioral: Healthy Lifestyle<br>* Diet and Exercise<br>* Other names: HL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | pre- and at the end of the intervention (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre- and at the end of the intervention (6 weeks) | 
| 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. | pre- and at the end of the intervention (6 weeks) | 
| 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. | pre- and at the end of the intervention (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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military, chronic pelvic pain, inflammation, mindfulness