Mindfulness in Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Mindfulness in Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123429
• Other study ID #: 276379
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: University of Arkansas
• Contact: Vivian Shi, MD
• Phone: 4153177138?
• Email: vshi[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.

Locations

Country	Name	City	State
United States	UAMS Dermatology Clinic	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 De — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.