Mindfulness in Hidradenitis Suppurativa

NCT06123429 | Completed

• 1 other identifier: 276379
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hidradenitis Suppurativa

Keywords

Quality of Life; Mindfulness

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

Secondary Outcomes (1)

• Hidradenitis Suppurativa Quality of Life Index (HiSQOL)

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

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Patient who recently began any psychotropic medication within 3 months prior to the baseline evaluation visit.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Dermatology Clinic

Little Rock, Arkansas, 72205, United States

Location

Related Publications (3)

• 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.

  PMID: 29355905 BACKGROUND

• 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.

  PMID: 28052274 BACKGROUND

• 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.

  PMID: 37163257 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vivian Shi, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single pilot group, up to 40 patients will enroll and all will receive intervention.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: November 8, 2023
• Study Start: October 3, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)