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).

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Behavioral: Mindfulness Based Stress reduction

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • UAMS Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; All participants enrolled in the study will be enrolled in the Mindfulness-Based Stress reduction course. The MBSR course will consist of weekly sessions lasting two and a half hours, involving lecture, meditation, and self-reflection. The first MBSR course will be ready for 10-12 participants in November 2023. The following course will start every month thereafter. The courses will be held online over Zoom.

Behavioral: Mindfulness Based Stress reduction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder (GAD7)	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	Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
Patient Health Questionaire (PHQ9)	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	Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
Dermatology Quality of Life Index (DLQI scores)	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	Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hidradenitis Suppurativa Quality of Life Index (HiSQOL)	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	Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Vivian Shi, MD, University of Arkansas

Publications and helpful links

General Publications

• Vekic DA, Frew J, Cains GD. Hidradenitis suppurativa, a review of pathogenesis, associations and management. Part 1. Australas J Dermatol. 2018 Nov;59(4):267-277. doi: 10.1111/ajd.12770. Epub 2018 Jan 21.
• Kouris A, Platsidaki E, Christodoulou C, Efstathiou V, Dessinioti C, Tzanetakou V, Korkoliakou P, Zisimou C, Antoniou C, Kontochristopoulos G. Quality of Life and Psychosocial Implications in Patients with Hidradenitis Suppurativa. Dermatology. 2016;232(6):687-691. doi: 10.1159/000453355. Epub 2017 Jan 5.
• Kishimoto S, Watanabe N, Yamamoto Y, Imai T, Aida R, Germer C, Tamagawa-Mineoka R, Shimizu R, Hickman S, Nakayama Y, Etoh T, Sahker E, Carnie MB, Furukawa TA. Efficacy of Integrated Online Mindfulness and Self-compassion Training for Adults With Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):628-636. doi: 10.1001/jamadermatol.2023.0975.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Mindfulness
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: 276379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No