Mindfulness Training Hidradenitis Suppurativa (HS)

NCT05642039 | Completed

• 1 other identifier: 20220907
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Dermatology Life Quality Index (DLQI) Scores

  Up to 10 weeks

• Number of participants at each Refined Hurley Classification

  Up to 10 weeks

• Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores

  Up to 10 weeks

• Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores

  Up to 10 weeks

• Pain Visual Analog Scale (VAS) Scores

  Up to 10 weeks

Study Arms (2)

Mindfulness Course Group

EXPERIMENTAL

Participants will participate in the mindfulness course that would last 6 weeks.

Behavioral: Mindfulness Course

HS Educational Course Group

EXPERIMENTAL

Participants will participate in the mindfulness course that would last 6 weeks.

Behavioral: HS Educational Course

Interventions

Mindfulness Course BEHAVIORAL

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.

Mindfulness Course Group

HS Educational Course BEHAVIORAL

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.

HS Educational Course Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: May 1, 2023
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)