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Completed

NCT Number: NCT05642039

Mindfulness Training Hidradenitis Suppurativa (HS)

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Quality of Life Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Dermatology Life Quality Index (DLQI) Scores

    Time frame: 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

  2. Number of participants at each Refined Hurley Classification

    Time frame: 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).

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

    Time frame: 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

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

    Time frame: Up to 10 weeks

    FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness.

  5. Pain Visual Analog Scale (VAS) Scores

    Time frame: Up to 10 weeks

    Pain VAS has a range from 0 to 10 with a higher score indicating worse pain

  6. Sleep Quality Scale (SQS) Scores

    Time frame: Up to 10 weeks

    Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality

  7. Number of Pain medication Usage

    Time frame: Up to 10 weeks

    Patient reported number of pain medications used by participants in the past week

  8. Number of work/school days missed

    Time frame: Up to 10 weeks

    Patient reported number of work/school days missed in the past week

  9. Number of visits to the emergency room

    Time frame: Up to 10 weeks

    Patient reported number of visits to the emergency room in the past week

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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