Mindfulness Training Hidradenitis Suppurativa (HS)

Not Applicable

Active, not recruiting

• Conditions: Hidradenitis Suppurativa; Quality of Life
• Interventions: Behavioral: HS Educational Course; Behavioral: Mindfulness Course

• Registration Number: NCT05642039
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Study Start: 2023-05-01
• Primary Completion: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS Educational Course Group	HS Educational Course	Participants will participate in the mindfulness course that would last 6 weeks.
Mindfulness Course Group	Mindfulness Course	Participants will participate in the mindfulness course that would last 6 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of work/school days missed	Up to 10 weeks	Patient reported number of work/school days missed in the past week
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).
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.
Number of Pain medication Usage	Up to 10 weeks	Patient reported number of pain medications used by participants in the past week
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
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 visits to the emergency room	Up to 10 weeks	Patient reported number of visits to the emergency room in the past week
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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States