Mindfulness in Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The study will investigate the impact of an 8-week-long Mindfulness-Based Stress Reduction course on quality of life and disease severity in patients with hidradenitis suppurativa (HS).

Detailed Description
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This is a voluntary 8-week-long, non-medical intervention study for patients with hidradenitis suppurativa (HS). This study will enroll participants in an 8-week-long Mindfulness-Based Stress Reduction course and observed for any changes in validated measures of quality of life. Quality of life scores will be evaluated via multiple surveys including the Dermatology Quality of Life index, HS Quality of Life index, GAD7, and PHQ9. Surveys will be collected Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. The first goal is to investigate the effectiveness of the addition of mindfulness-based stress reduction (MBSR) intervention to conventional medical treatment on improving mental health in HS participants. The second goal is to assess participant preference for MBSR intervention.

Official Title
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Mindfulness in Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will only enroll subjects between the ages of 18-years and 89-years of age. Diagnosis of HS Able to read and comprehend study materials in English, ie: surveys Exclusion Criteria: Those who do not fit inclusion criteria Non-English speaking Patient who recently began any psychotropic medication within 3 months prior to the baseline evaluation visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single pilot group, up to 40 patients will enroll and all will receive intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>All participants enrolled in the study will be enrolled in the Mindfulness-Based Stress reduction course. The MBSR course will consist of weekly sessions lasting two and a half hours, involving lecture, meditation, and self-reflection. The first MBSR course will be ready for 10-12 participants in November 2023. The following course will start every month thereafter. The courses will be held online over Zoom. | Behavioral: Mindfulness Based Stress reduction<br>* The MBSR course will consist of weekly sessions lasting two and a half hours, involving lecture, meditation, and self-reflection. Mindfulness-Based Stress Reduction (MBSR) is a structured program designed to help individuals manage stress, increase self-awareness, and promote overall well-being. Developed by Dr. Jon Kabat-Zinn in the late 1970s, MBSR combines elements of mindfulness meditation and cognitive-behavioral techniques. MBSR is a comprehensive program that equips individuals with practical skills to better manage stress and enhance their mental and emotional well-being. Its emphasis on mindfulness, self-awareness, and the integration of these practices into daily life makes it a valuable resource for those seeking to reduce stress and improve their overall quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Quality of Life Index (DLQI scores) | Change in DLQI scores before and after Mindfulness Based Stress Reduction course. DLQI score interpretation: 0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life | Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. | 
| Generalized Anxiety Disorder (GAD7) | Change in GAD7 scores before and after Mindfulness Based Stress Reduction course. This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of not at all, several days, more than half the days, and nearly every day. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. | 
| Patient Health Questionaire (PHQ9) | Change in PHQ9 scores before and after Mindfulness-Based Stress Reduction course. Scoring: add up all checked boxes on PHQ-9 For every 3 Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3 Interpretation of Total Score Total Score Depression Severity 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression | Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidradenitis Suppurativa Quality of Life Index (HiSQOL) | Change in HiSQOL scores before and after Mindfulness-Based Stress Reduction course. Grading: Not at all = 0 points Slightly = 1 point Moderately = 2 points Very much = 3 points Extremely = 4 points 0-17 = No effect 18-34 = Small effect 35-51 = Moderate effect 52-68 = Severe effect Max score = 68 points | Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Mindfulness