Mindfulness Training Hidradenitis Suppurativa (HS)

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642039
• Other study ID #: 20220907
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Aliette Espinosa
• Phone: 305-689-3376
• Email: a.espinosa2[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Pain medication Usage	Patient reported number of pain medications used by participants in the past week	Up to 10 weeks
Secondary	Number of work/school days missed	Patient reported number of work/school days missed in the past week	Up to 10 weeks
Secondary	Number of visits to the emergency room	Patient reported number of visits to the emergency room in the past week	Up to 10 weeks