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NCT Number: NCT06123429

Mindfulness in Hidradenitis Suppurativa

The study will investigate the impact of an 8-week-long Mindfulness-Based Stress Reduction course on quality of life and disease severity in patients with hidradenitis suppurativa (HS).

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Dermatology Clinic

Little Rock, Arkansas, 72205, United States

About this study

This is a voluntary 8-week-long, non-medical intervention study for patients with hidradenitis suppurativa (HS). This study will enroll participants in an 8-week-long Mindfulness-Based Stress Reduction course and observed for any changes in validated measures of quality of life. Quality of life scores will be evaluated via multiple surveys including the Dermatology Quality of Life index, HS Quality of Life index, GAD7, and PHQ9. Surveys will be collected Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. The first goal is to investigate the effectiveness of the addition of mindfulness-based stress reduction (MBSR) intervention to conventional medical treatment on improving mental health in HS participants. The second goal is to assess participant preference for MBSR intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study will only enroll subjects between the ages of 18-years and 89-years of age.
  • Diagnosis of HS
  • Able to read and comprehend study materials in English, ie: surveys

Exclusion criteria

  • Those who do not fit inclusion criteria
  • Non-English speaking
  • Patient who recently began any psychotropic medication within 3 months prior to the baseline evaluation visit.

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

The MBSR course will consist of weekly sessions lasting two and a half hours, involving lecture, meditation, and self-reflection.

Mindfulness-Based Stress Reduction (MBSR) is a structured program designed to help individuals manage stress, increase self-awareness, and promote overall well-being. Developed by Dr. Jon Kabat-Zinn in the late 1970s, MBSR combines elements of mindfulness meditation and cognitive-behavioral techniques. MBSR is a comprehensive program that equips individuals with practical skills to better manage stress and enhance their mental and emotional well-being. Its emphasis on mindfulness, self-awareness, and the integration of these practices into daily life makes it a valuable resource for those seeking to reduce stress and improve their overall quality of life.

Primary outcomes

  1. Dermatology Quality of Life Index (DLQI scores)

    Time frame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12

    Change in DLQI scores before and after Mindfulness Based Stress Reduction course.

    DLQI score interpretation:

    0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life

  2. Generalized Anxiety Disorder (GAD7)

    Time frame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.

    Change in GAD7 scores before and after Mindfulness Based Stress Reduction course. This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

  3. Patient Health Questionaire (PHQ9)

    Time frame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.

    Change in PHQ9 scores before and after Mindfulness-Based Stress Reduction course.

    Scoring: add up all checked boxes on PHQ-9 For every 3 Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3 Interpretation of Total Score

    Total Score Depression Severity 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression

Secondary outcomes

  1. Hidradenitis Suppurativa Quality of Life Index (HiSQOL)

    Time frame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.

    Change in HiSQOL scores before and after Mindfulness-Based Stress Reduction course.

    Grading:

    Not at all = 0 points Slightly = 1 point Moderately = 2 points Very much = 3 points Extremely = 4 points

    0-17 = No effect 18-34 = Small effect 35-51 = Moderate effect 52-68 = Severe effect

    Max score = 68 points

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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