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Mindfulness Training Hidradenitis Suppurativa (HS)

Primary Purpose

Hidradenitis Suppurativa, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Course
HS Educational Course
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mindfulness Course Group

HS Educational Course Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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).
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
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.
Pain Visual Analog Scale (VAS) Scores
Pain VAS has a range from 0 to 10 with a higher score indicating worse pain
Sleep Quality Scale (SQS) Scores
Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality
Number of Pain medication Usage
Patient reported number of pain medications used by participants in the past week
Number of work/school days missed
Patient reported number of work/school days missed in the past week
Number of visits to the emergency room
Patient reported number of visits to the emergency room in the past week

Full Information

First Posted
November 29, 2022
Last Updated
May 9, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05642039
Brief Title
Mindfulness Training Hidradenitis Suppurativa (HS)
Official Title
Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Course Group
Arm Type
Experimental
Arm Description
Participants will participate in the mindfulness course that would last 6 weeks.
Arm Title
HS Educational Course Group
Arm Type
Experimental
Arm Description
Participants will participate in the mindfulness course that would last 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Course
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HS Educational Course
Intervention Description
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 Outcome Measure Information:
Title
HS Quality of Life Measure (HiSQOL) Scores
Description
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
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI) Scores
Description
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
Time Frame
Up to 10 weeks
Title
Number of participants at each Refined Hurley Classification
Description
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).
Time Frame
Up to 10 weeks
Title
Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores
Description
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
Time Frame
Up to 10 weeks
Title
Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores
Description
FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness.
Time Frame
Up to 10 weeks
Title
Pain Visual Analog Scale (VAS) Scores
Description
Pain VAS has a range from 0 to 10 with a higher score indicating worse pain
Time Frame
Up to 10 weeks
Title
Sleep Quality Scale (SQS) Scores
Description
Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality
Time Frame
Up to 10 weeks
Title
Number of Pain medication Usage
Description
Patient reported number of pain medications used by participants in the past week
Time Frame
Up to 10 weeks
Title
Number of work/school days missed
Description
Patient reported number of work/school days missed in the past week
Time Frame
Up to 10 weeks
Title
Number of visits to the emergency room
Description
Patient reported number of visits to the emergency room in the past week
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliette Espinosa
Phone
305-689-3376
Email
a.espinosa2@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Phone
305-243-8485
Email
hlevtov@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness Training Hidradenitis Suppurativa (HS)

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