Hidradenitis Suppurativa
Conditions
Keywords
Quality of Life, Mindfulness
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.
Interventions
BEHAVIORALMindfulness Based Stress reduction
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.
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single pilot group, up to 40 patients will enroll and all will receive intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 life |
| Generalized 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed