~6 spots leftby Aug 2025

Mindfulness Training for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)
Dr. Hadar Avihai Lev-Tov, MD - Miami ...
Overseen byHadar Lev-Tov, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Disqualifiers: Active drug addictions, untreated PTSD, psychosis, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.
Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for Hidradenitis Suppurativa?

Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) have been shown to improve psychological distress and quality of life in breast cancer patients, suggesting potential benefits for managing stress and improving well-being in other conditions like Hidradenitis Suppurativa.

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Is mindfulness training safe for humans?

Mindfulness training, including programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is generally considered safe for most people. These programs have been used for various conditions and are typically well-tolerated, with few reported side effects.

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How is mindfulness training different from other treatments for hidradenitis suppurativa?

Mindfulness training, unlike traditional medical treatments, focuses on teaching self-regulation skills to manage stress and emotions, which can help patients cope with the psychological and emotional challenges of living with hidradenitis suppurativa.

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Eligibility Criteria

This trial is for adults with Hidradenitis Suppurativa (HS) who are registered at the University of Miami Hospital dermatology system. Participants must speak English and be able to consent. It's not for those under 18, pregnant women, prisoners, individuals with active drug addictions, psychosis or suicidal thoughts, or untreated PTSD.

Inclusion Criteria

People who are being treated for Hidradenitis Suppurativa at the University of Miami Hospital dermatology department.
I currently have tumors or lesions.

Exclusion Criteria

I am under 18 years old.
Prisoners
I am unable to give consent for myself.
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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Training

Participants will participate in the mindfulness course that lasts 6 weeks

6 weeks

Follow-up

Participants are monitored for quality of life and other outcomes after the mindfulness training

4 weeks

Participant Groups

The study is testing whether a mindfulness training course can improve the quality of life in HS patients compared to an educational course about HS. Patients will learn techniques aimed at reducing stress and improving mental well-being.
2Treatment groups
Experimental Treatment
Group I: Mindfulness Course GroupExperimental Treatment1 Intervention
Participants will participate in the mindfulness course that would last 6 weeks.
Group II: HS Educational Course GroupExperimental Treatment1 Intervention
Participants will participate in the mindfulness course that would last 6 weeks.

Mindfulness Course is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Mindfulness Course for:
  • Stress reduction
  • Anxiety management
  • Chronic pain management
  • Improvement of quality of life for Hidradenitis Suppurativa (HS) patients
🇺🇸 Approved in United States as Mindfulness Course for:
  • Stress reduction
  • Anxiety management
  • Chronic pain management
  • Improvement of quality of life for Hidradenitis Suppurativa (HS) patients
🇨🇦 Approved in Canada as Mindfulness Course for:
  • Stress reduction
  • Anxiety management
  • Chronic pain management
  • Improvement of quality of life for Hidradenitis Suppurativa (HS) patients

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?

University of MiamiLead Sponsor

References

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]The aim of this systematic review and meta-analysis was to assess the effectiveness of mindfulness-based stress reduction (mbsr) and mindfulness-based cognitive therapy (mbct) in patients with breast cancer.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.
Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. [2022]The aim of this meta-analysis was to systematically update the evidence for mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) in women with breast cancer.
Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]Mindfulness interventions can improve psychological distress and quality of life (QoL) in cancer survivors. Few mindfulness programs for cancer recovery exist in Southeastern U.S. The primary objective of this study was to assess the feasibility of a modified mindfulness-based stress reduction (MBSR) program for breast cancer patients in Birmingham, Alabama. The secondary objective was to explore potential program effects on mindfulness skills and QoL.
Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. [2022]Group-based mindfulness training is frequently described in psycho-oncology literature, but little is known of the effectiveness of mindfulness-based cognitive therapy (MBCT). We investigated the effectiveness and acceptability of MBCT for women with breast and gynecologic cancer.
6.Czech Republicpubmed.ncbi.nlm.nih.gov
[Hidradenitis suppurativa - symptoms, diagnostics, and therapy]. [2019]Hidradenitis suppurativa is a chronic skin disorder characterized by recurrent inflammatory nodules, fistulas, abscesses, and scarring mainly in the intertriginous areas with terminal hair and apocrine glands. Hidradenitis suppurativa manifests usually after puberty, in the third life decade and persists for many years. The prevalence of the disease is estimated to be 0,5 % in the Czech Republic. Women are most often affected in the axillary and inguinal parts, while men in the perianal and gluteal areas. The exact pathogenesis is still unknown. It is assumed that hyperkeratosis of the hair follicle leads to its occlusion, dilatation and further rupture when keratin and bacteria are spilled into the dermis causing a massive inflammatory reaction. Smoking and obesity belong to the main triggering factors. Without therapy, the disease is chronic and progressive. The standard therapy depends on the extension of the disorder. For not extensive lesions, treatment consists of topical antiseptics, antibiotics or long- term therapy with systemic antibiotics. In more advanced stages, systemic therapy with TNF-α antagonists is needed. Further therapeutic modality is surgical intervention and wide excision of the affected area. Nevertheless, recurrences in the adjacent tissue cannot be avoided.
Non-surgical treatments for hidradenitis suppurativa: A systematic review. [2018]The management of hidradenitis suppurativa is multidisciplinary, involving general measures, medical treatment and surgery. Non-surgical treatments, often first-line procedures, mainly concern forms of low-to-moderate severity or, conversely, very severe forms in non-operable patients or those refusing surgery. While many treatments have been attempted, few randomized controlled trials have been conducted, so the choice of treatments is most often based on the personal experience of the clinicians. The objective of this systematic review is to propose a synthetic analysis of the currently available non-surgical procedures.
Targeting Metabolic Syndrome in Hidradenitis Suppurativa by Phytochemicals as a Potential Complementary Therapeutic Strategy. [2023]Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by the appearance of painful inflamed nodules, abscesses, and pus-draining sinus tracts in the intertriginous skin of the groins, buttocks, and perianal and axillary regions. Despite its high prevalence of ~0.4-1%, therapeutic options for HS are still limited. Over the past 10 years, it has become clear that HS is a systemic disease, associated with various comorbidities, including metabolic syndrome (MetS) and its sequelae. Accordingly, the life expectancy of HS patients is significantly reduced. MetS, in particular, obesity, can support sustained inflammation and thereby exacerbate skin manifestations and the chronification of HS. However, MetS actually lacks necessary attention in HS therapy, underlining the high medical need for novel therapeutic options. This review directs attention towards the relevance of MetS in HS and evaluates the potential of phytomedical drug candidates to alleviate its components. It starts by describing key facts about HS, the specifics of metabolic alterations in HS patients, and mechanisms by which obesity may exacerbate HS skin alterations. Then, the results from the preclinical studies with phytochemicals on MetS parameters are evaluated and the outcomes of respective randomized controlled clinical trials in healthy people and patients without HS are presented.
Opioid, alcohol, and cannabis misuse among patients with hidradenitis suppurativa: A population-based analysis in the United States. [2021]Patients with hidradenitis suppurativa (HS) experience chronic pain and have significant physical, emotional, and psychological disease impact. These patients may be at risk for substance abuse.
Sub-classification of Hidradenitis suppurativa: a cross-sectional study. [2022]The typical Hidradenitis Suppurativa (HS) patient is a young woman with axillary and groin involvement, but the spectrum of the disease presentation is broad and no internationally acknowledged sub-classification of the disease exists to date. It is however speculated that different, yet unidentified, subtypes may respond differently to different treatments or carry a different prognosis. Classification according to self-reported clinically meaningful outcomes for patients offer practical advantages. Our objective was to build an empirical framework for sub-classification of HS patients based on the frequency of HS flares in various anatomic locations, using a cross-sectional questionnaire-based design. All patients with a clinically confirmed diagnosis of HS registered at our department until March 1, 2017 were invited to participate. The frequency of HS flares in various anatomic locations was used for identification of possible HS subtypes using Principal Component Analysis (PCA) and cluster analysis. A total of 524 (62%) of 845 invited patients answered the questionnaire; 402 (76.7%) were female. From the cluster analysis, we identified two possible subtypes of HS, labeled the "upper type" and the "lower type". The "upper type" was characterized by repeated outbreaks in axillary and mammary regions. Meanwhile, the "lower type" was characterized by outbreaks in the inguinal, genital, perianal, and gluteal regions. Our findings support the notion that HS can be sub-classified and imply that the pattern of where lesions are located may be an important element in future HS sub-classification systems.
Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]Graduate healthcare students experience significant stressors during professional training. Mindfulness-Based Stress Reduction (MBSR) is a behavioural intervention designed to teach self-regulatory skills for stress reduction and emotion management. This study examines the impact of MBSR training on students from five healthcare graduate programs in a quasi-experimental trial.
12.United Statespubmed.ncbi.nlm.nih.gov
Mindfulness and people with stomas. [2019]Persons with a stoma must contend not only with the immediate physical changes produced by the operation but also with psychologic adjustments, changes in body image, changes in self-concept, and the chronic stress of stoma care and physical functioning. Mindfulness training can enable these persons to make the necessary adjustments in a more realized and conscious manner. The practice of mindfulness training has been demonstrated to be effective in dealing with clinical and psychologic problems. Mindfulness is defined as being fully awake and is characterized as being nonjudging, having a beginner's mind, being trusting, nonstriving, accepting, and letting go. Mindfulness training is described, and roadblocks to the practice of mindfulness are discussed and exemplified. Resources on the practice of mindfulness and applications to persons with ostomies are provided. Mindfulness training is proposed as an adjunct to patient education or support groups.
Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group. [2023]Mindfulness facets can be trained with structured mindfulness interventions, but little is known regarding application on a broader level within sex therapy (e.g. men, partners and different sexual dysfunctions).