Mindfulness Training Hidradenitis Suppurativa (HS)

Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients

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 Overview

• Status: Completed
• Conditions: Quality of Life; Hidradenitis Suppurativa
• Intervention / Treatment: Behavioral: Mindfulness Course; Behavioral: HS Educational Course

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HS Quality of Life Measure (HiSQOL) Scores	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	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI) Scores	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	Up to 10 weeks
Number of participants at each Refined Hurley Classification	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).	Up to 10 weeks
Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores	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	Up to 10 weeks
Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores	FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness.	Up to 10 weeks
Pain Visual Analog Scale (VAS) Scores	Pain VAS has a range from 0 to 10 with a higher score indicating worse pain	Up to 10 weeks
Sleep Quality Scale (SQS) Scores	Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality	Up to 10 weeks
Number of Pain medication Usage	Patient reported number of pain medications used by participants in the past week	Up to 10 weeks
Number of work/school days missed	Patient reported number of work/school days missed in the past week	Up to 10 weeks
Number of visits to the emergency room	Patient reported number of visits to the emergency room in the past week	Up to 10 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: 20220907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No