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

Not Applicable

Completed

• Conditions: Inflammation Pelvic; Chronic Pelvic Pain; Depression
• Interventions: Behavioral: Healthy Lifestyle; Behavioral: Mindfulness based stress reduction

• Registration Number: NCT04104542
• Lead Sponsor: University of Missouri, Kansas City

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?

Study Timeline

• Study First Submitted: 2019-05-01
• Study Start: 2019-06-01
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-26
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-09
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Lifestyle JBSA	Healthy Lifestyle	online healthy lifestyle training
Healthy Lifestyle MTHM	Healthy Lifestyle	online healthy lifestyle training
Mindfulness MTHM	Mindfulness based stress reduction	online mindfulness based stress reduction training
Mindfulness JBSA	Mindfulness based stress reduction	online mindfulness based stress reduction training

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory Questionnaire measuring participants pelvic pain	pre- and at the end of the intervention (6 weeks)	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

Name	Time	Method
Five Facets of Mindfulness Questionnaire measuring mindfulness	pre- and at the end of the intervention (6 weeks)	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	pre- and at the end of the intervention (6 weeks)	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	pre- and at the end of the intervention (6 weeks)	Elisa's were used to measure changes in inflammation using ng/ml before and after interventions.

Trial Locations

Locations (1)

Univeristy of Missouri-Kansas City; 🇺🇸 Kansas City, Missouri, United States