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

Depression Clinical Trial

— AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104542
• Other study ID #: 18-078
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: July 2022
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Depression
• Inflammation
• Inflammation Pelvic
• Pelvic Inflammatory Disease
• Pelvic Pain

Intervention

Behavioral:
• Mindfulness based stress reduction
on-line training on the website = www.palousemindfulness.com
• Healthy Lifestyle
Diet and Exercise

Locations

Country	Name	City	State
United States	Univeristy of Missouri-Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)