Mindfulness in Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Registration Number
- NCT06123429
- Lead Sponsor
- University of Arkansas
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dermatology Quality of Life Index (DLQI scores) Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12 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 lifeGeneralized Anxiety Disorder (GAD7) Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. 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
Patient Health Questionaire (PHQ9) Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. 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
- Secondary Outcome Measures
Name Time Method Hidradenitis Suppurativa Quality of Life Index (HiSQOL) Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. 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
Trial Locations
- Locations (1)
UAMS Dermatology Clinic
🇺🇸Little Rock, Arkansas, United States