Mindfulness Training Hidradenitis Suppurativa (HS)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness Course Group Participants will participate in the mindfulness course that would last 6 weeks. |
Behavioral: Mindfulness Course
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.
|
| Experimental: HS Educational Course Group Participants will participate in the mindfulness course that would last 6 weeks. |
Behavioral: HS Educational Course
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.
|
Outcome Measures
Primary Outcome Measures
- HS Quality of Life Measure (HiSQOL) Scores [Up to 10 weeks]
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
Secondary Outcome Measures
- Dermatology Life Quality Index (DLQI) Scores [Up to 10 weeks]
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
- Number of participants at each Refined Hurley Classification [Up to 10 weeks]
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).
- Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores [Up to 10 weeks]
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
- Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores [Up to 10 weeks]
FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness.
- Pain Visual Analog Scale (VAS) Scores [Up to 10 weeks]
Pain VAS has a range from 0 to 10 with a higher score indicating worse pain
- Sleep Quality Scale (SQS) Scores [Up to 10 weeks]
Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality
- Number of Pain medication Usage [Up to 10 weeks]
Patient reported number of pain medications used by participants in the past week
- Number of work/school days missed [Up to 10 weeks]
Patient reported number of work/school days missed in the past week
- Number of visits to the emergency room [Up to 10 weeks]
Patient reported number of visits to the emergency room in the past week
Eligibility Criteria
Criteria
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:
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Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations
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Adults unable to consent
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Pregnant women
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Prisoners
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Individuals below the age of 18 years old
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Individuals who do not speak English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Hadar Lev-Tov, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220907