Mindfulness Training for Hidradenitis Suppurativa

Overseen By Aliette Espinosa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Active drug addictions, untreated PTSD, psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 3 11 12 13}

Research Team

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.

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 Overview 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.

Participant Groups

Group I: Mindfulness Course Group Experimental Treatment 1 Intervention

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

Group II: HS Educational Course Group Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. Haller, H., Winkler, MM., Klose, P., et al.[2022]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduced distress and improved quality of life, mindfulness, and post-traumatic growth in a study of 50 women with breast and gynecologic cancer, with improvements maintained three months after the intervention.

Participants found the group-based MBCT program beneficial, indicating high acceptability, and the results suggest that MBCT could offer psychosocial benefits for women with cancer, although further randomized trials are needed for more definitive evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. Stafford, L., Foley, E., Judd, F., et al.[2022]

Hidradenitis suppurativa is a chronic skin condition that typically appears after puberty and can persist for many years, affecting about 0.5% of the population in the Czech Republic, with women commonly affected in the axillary and inguinal areas and men in the perianal and gluteal regions.

The disease is characterized by recurrent inflammatory nodules and abscesses, and while treatment options range from topical antiseptics and antibiotics for mild cases to TNF-α antagonists and surgical interventions for more severe cases, recurrences in nearby tissues are common, indicating the need for ongoing management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hidradenitis suppurativa - symptoms, diagnostics, and therapy]. Arenbergerová, M., Dahmen, RA., Arenberger, P.[2019]

A systematic review of 64 articles on non-surgical treatments for hidradenitis suppurativa found that while antibiotics and biotherapy show some effectiveness, they do not provide long-term remission and the disease often returns after treatment stops.

Due to the limited effectiveness and potential side effects of non-surgical options, radical surgery is recommended for severe or resistant cases, as it offers the best chance for a cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-surgical treatments for hidradenitis suppurativa: A systematic review. Robert, E., Bodin, F., Paul, C., et al.[2018]

Hidradenitis suppurativa (HS) is a chronic inflammatory disease that significantly reduces life expectancy and is often associated with metabolic syndrome (MetS), highlighting the need for better treatment options.

The review emphasizes the potential of phytomedical drug candidates to address components of MetS in HS patients, suggesting that targeting metabolic issues may improve HS symptoms and overall patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Metabolic Syndrome in Hidradenitis Suppurativa by Phytochemicals as a Potential Complementary Therapeutic Strategy. Witte, K., Wolk, K., Witte-Händel, E., et al.[2023]

In a study of 32,625 patients with hidradenitis suppurativa (HS), the prevalence of substance use disorder (SUD) was found to be 4.0%, significantly higher than the 2.0% prevalence in patients without HS, indicating a strong association between HS and increased risk of SUD.

The most common substances misused by HS patients were alcohol (47.9%), opioids (32.7%), and cannabis (29.7%), with patients having 1.50 times the odds of developing SUD compared to those without HS, suggesting a need for regular screening for substance abuse in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid, alcohol, and cannabis misuse among patients with hidradenitis suppurativa: A population-based analysis in the United States. Garg, A., Papagermanos, V., Midura, M., et al.[2021]

A study involving 524 patients with Hidradenitis Suppurativa (HS) identified two potential subtypes based on the frequency of flares in different body areas: the 'upper type' (axillary and mammary regions) and the 'lower type' (inguinal, genital, perianal, and gluteal regions).

This classification suggests that the location of HS lesions may influence treatment responses and prognosis, highlighting the need for a more tailored approach to managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sub-classification of Hidradenitis suppurativa: a cross-sectional study. Thorlacius, L., Riis, PT., List, EK., et al.[2022]

Mindfulness-Based Stress Reduction (MBSR) significantly decreased anxiety levels in healthcare graduate students after 8 weeks of training, with improvements maintained at 3 weeks post-course.

MBSR also increased empathy among students at the end of the program, although this effect did not persist at the 3-week follow-up, and no significant changes in burnout were observed between the intervention and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Barbosa, P., Raymond, G., Zlotnick, C., et al.[2013]

Mindfulness training can help individuals with a stoma cope with the psychological and emotional challenges that arise from their condition, such as changes in body image and self-concept.

The practice of mindfulness, which involves being fully present and accepting, is suggested as a valuable addition to patient education and support for those adjusting to life with a stoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and people with stomas. Trunnell, EP.[2019]

The 8-week mindfulness for sex and intimacy in relationships (MSIR) intervention was found to be feasible and well-received, with high acceptance and completion rates among the 34 participants, indicating its potential for clinical use alongside standard treatment.

Participants receiving MSIR in addition to treatment as usual (TAU) reported significantly greater reductions in distress related to sexual problems compared to those receiving only TAU, suggesting that mindfulness can enhance the effectiveness of traditional therapies for sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group. Krieger, JF., Kristensen, E., Marquardsen, M., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive group therapy for women with breast and gynecologic cancer: a pilot study to determine effectiveness and feasibility. [2022]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Hidradenitis suppurativa - symptoms, diagnostics, and therapy]. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Non-surgical treatments for hidradenitis suppurativa: A systematic review. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Metabolic Syndrome in Hidradenitis Suppurativa by Phytochemicals as a Potential Complementary Therapeutic Strategy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Opioid, alcohol, and cannabis misuse among patients with hidradenitis suppurativa: A population-based analysis in the United States. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Sub-classification of Hidradenitis suppurativa: a cross-sectional study. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Mindfulness and people with stomas. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group. [2023]