30 Participants Needed

Mindfulness Training for Hidradenitis Suppurativa

AE
Overseen ByAliette Espinosa
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

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.13111213

Research Team

Dr. Hadar Avihai Lev-Tov, MD - Miami ...

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

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.
See 5 more

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

Treatment Details

Interventions

  • HS Educational Course
  • Mindfulness Course
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Findings from Research

Mindfulness-based stress reduction (MBSR) significantly reduces depression and anxiety in breast cancer patients compared to usual care, based on a systematic review of three randomized controlled trials involving 327 subjects.
While MBSR shows promise in improving psychological health, it does not significantly increase spirituality, indicating that its benefits may be more focused on mental health rather than spiritual well-being.
Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis.Cramer, H., Lauche, R., Paul, A., et al.[2021]
Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.
Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy.Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]
Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) significantly improved health-related quality of life, fatigue, sleep, stress, anxiety, and depression in women with breast cancer, based on a meta-analysis of 10 studies involving 1709 participants.
While these interventions showed short-term effectiveness, the average effects were below the threshold for minimal clinically important differences, indicating that while beneficial, their clinical relevance may need further investigation.
Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis.Haller, H., Winkler, MM., Klose, P., et al.[2022]

References

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]
Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. [2022]
Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]
Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. [2022]
6.Czech Republicpubmed.ncbi.nlm.nih.gov
[Hidradenitis suppurativa - symptoms, diagnostics, and therapy]. [2019]
Non-surgical treatments for hidradenitis suppurativa: A systematic review. [2018]
Targeting Metabolic Syndrome in Hidradenitis Suppurativa by Phytochemicals as a Potential Complementary Therapeutic Strategy. [2023]
Opioid, alcohol, and cannabis misuse among patients with hidradenitis suppurativa: A population-based analysis in the United States. [2021]
Sub-classification of Hidradenitis suppurativa: a cross-sectional study. [2022]
Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Mindfulness and people with stomas. [2019]
Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group. [2023]