MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
AD
MOCHI: A Randomized Controlled Trial of Mindfulness as a Treatment for Chronic Pelvic Pain in Active Duty Women
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedJuly 12, 2022
July 1, 2022
4 months
May 1, 2019
July 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Five Facets of Mindfulness Questionnaire measuring mindfulness
pre- and at the end of the intervention (6 weeks)
Patient Health Questionnaire -9 (PHQ-9) measuring 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
pre- and at the end of the intervention (6 weeks)
Study Arms (4)
Mindfulness MTHM
EXPERIMENTALonline mindfulness based stress reduction training
Mindfulness JBSA
EXPERIMENTALonline mindfulness based stress reduction training
Healthy Lifestyle MTHM
SHAM COMPARATORonline healthy lifestyle training
Healthy Lifestyle JBSA
SHAM COMPARATORonline healthy lifestyle training
Interventions
on-line training on the website = www.palousemindfulness.com
Diet and Exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Missouri-Kansas City
Kansas City, Missouri, 64108, United States
Related Publications (1)
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.
PMID: 36251868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol D Crisp, PhD (c)
University of Missouri, Kansas City
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 1, 2019
First Posted
September 26, 2019
Study Start
June 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 31, 2019
Last Updated
July 12, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share