Hidradenitis SuppurativaNCT05642039
Mindfulness Training Hidradenitis Suppurativa (HS)
A study testing Mindfulness Course and HS Educational Course in people with Hidradenitis Suppurativa and Quality of Life, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa, Quality of Life
- What is being tested?
- Mindfulness Course and HS Educational Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
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
- Being tested
- Mindfulness Course, HS Educational Course
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness CourseBehavioural
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 CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Course Group | Experimental | Participants will participate in the mindfulness course that would last 6 weeks. Receives: Behavioral: Mindfulness Course |
| HS Educational Course Group | Experimental | Participants will participate in the mindfulness course that would last 6 weeks. Receives: Behavioral: HS Educational Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 10 weeks
Secondary outcomes (9)
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
Measured: Up to 10 weeks
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).
Measured: Up to 10 weeks
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
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
Pain Visual Analog Scale (VAS) Scores
Pain VAS has a range from 0 to 10 with a higher score indicating worse pain
Measured: Up to 10 weeks
Sleep Quality Scale (SQS) Scores
Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality
Measured: Up to 10 weeks
Number of Pain medication Usage
Patient reported number of pain medications used by participants in the past week
Measured: Up to 10 weeks
Number of work/school days missed
Patient reported number of work/school days missed in the past week
Measured: Up to 10 weeks
Number of visits to the emergency room
Patient reported number of visits to the emergency room in the past week
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 May 2023
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642039
- Sponsor's protocol ID
- 20220907
- Status last verified
- Aug 2025
- First submitted
- 29 Nov 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
- ClinicalTrials.gov ID
- NCT05642039
- Acronym / sponsor ID
- 20220907
- Conditions
- Hidradenitis Suppurativa, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Course Group | Experimental | Behavioral: Mindfulness CourseParticipants will participate in the mindfulness course that would last 6 weeks. |
| HS Educational Course Group | Experimental | Behavioral: HS Educational CourseParticipants will participate in the mindfulness course that would last 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness CourseParticipants 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. | Behavioural | Mindfulness Course Group |
| HS Educational CourseParticipants 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. | Behavioural | HS Educational Course Group |
Primary outcome
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
9 secondary outcomes
Dermatology Life Quality Index (DLQI) Scores
Time frame: Up to 10 weeks
Number of participants at each Refined Hurley Classification
Time frame: Up to 10 weeks
Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores
Time frame: Up to 10 weeks
Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores
Time frame: Up to 10 weeks
Pain Visual Analog Scale (VAS) Scores
Time frame: Up to 10 weeks
Sleep Quality Scale (SQS) Scores
Time frame: Up to 10 weeks
Number of Pain medication Usage
Time frame: Up to 10 weeks
Number of work/school days missed
Time frame: Up to 10 weeks
Number of visits to the emergency room
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Course and HS Educational Course in people with Hidradenitis Suppurativa and Quality of Life, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HS Quality of Life Measure (HiSQOL) Scores (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.