NCT05642039CompletedNot Applicable
Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- HS Quality of Life Measure (HiSQOL) Scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mindfulness Course Group
Experimental
Participants will participate in the mindfulness course that would last 6 weeks.
Intervention: Mindfulness Course (Behavioral)
HS Educational Course Group
Experimental
Participants will participate in the mindfulness course that would last 6 weeks.
Intervention: HS Educational Course (Behavioral)
Outcomes
Primary Outcomes
HS Quality of Life Measure (HiSQOL) Scores
Time Frame: 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 Outcomes
- Sleep Quality Scale (SQS) Scores(Up to 10 weeks)
- Dermatology Life Quality Index (DLQI) Scores(Up to 10 weeks)
- Number of participants at each Refined Hurley Classification(Up to 10 weeks)
- Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores(Up to 10 weeks)
- Number of Pain medication Usage(Up to 10 weeks)
- Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores(Up to 10 weeks)
- Number of work/school days missed(Up to 10 weeks)
- Number of visits to the emergency room(Up to 10 weeks)
- Pain Visual Analog Scale (VAS) Scores(Up to 10 weeks)
Investigators
Hadar Lev-Tov
Associate Professor of Clinical
University of Miami
Study Sites (1)
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