Mindfulness Training Hidradenitis Suppurativa (HS)

Study Overview
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Brief Summary
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The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.

Official Title
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Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients

Conditions
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Hidradenitis Suppurativa, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness Course
* Behavioral: HS Educational Course


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation Exclusion Criteria: Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations Adults unable to consent Pregnant women Prisoners Individuals below the age of 18 years old Individuals who do not speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Course Group<br>Participants will participate in the mindfulness course that would last 6 weeks. | Behavioral: Mindfulness Course<br>* Participants will attend a weekly 1.5-hour class over a 6-week period via Zoom. Participants will also be required to listen to guided practice audio recordings that are 12-20 minutes long and complete a weekly homework log detailing all audio recordings completed.<br>|
| Experimental: HS Educational Course Group<br>Participants will participate in the mindfulness course that would last 6 weeks. | Behavioral: HS Educational Course<br>* Participants will meet for 10 -15 minutes once a week over a 6-week period. The course will be administered verbally or with the use of PowerPoint slides.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HS Quality of Life Measure (HiSQOL) Scores | HS quality of life (HiSQOL) has a total score ranging from 0 to 68, with higher scores indicating more severe impact on participant's quality of life | Up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI) Scores | Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life | Up to 10 weeks | 
| Number of participants at each Refined Hurley Classification | The Hurley Classification is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening normal skin). | Up to 10 weeks | 
| Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores | HS Physician's Global Assessment (HS-PGA) Scale is a 6-point Likert scale from 0 (clear) to 5 (very severe). Total score ranges from 0 to 30 with the higher score indicating more severe HS symptoms | Up to 10 weeks | 
| Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores | FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness. | Up to 10 weeks | 
| Pain Visual Analog Scale (VAS) Scores | Pain VAS has a range from 0 to 10 with a higher score indicating worse pain | Up to 10 weeks | 
| Sleep Quality Scale (SQS) Scores | Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality | Up to 10 weeks | 
| Number of Pain medication Usage | Patient reported number of pain medications used by participants in the past week | Up to 10 weeks | 
| Number of work/school days missed | Patient reported number of work/school days missed in the past week | Up to 10 weeks | 
| Number of visits to the emergency room | Patient reported number of visits to the emergency room in the past week | Up to 10 weeks |