Clinical trial NCT06123429: Mindfulness in Hidradenitis Suppurativa
Official title: Mindfulness in Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: Quality of Life
Mindfulness
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single pilot group, up to 40 patients will enroll and all will receive intervention.
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dermatology Quality of Life Index (DLQI scores)
timeFrame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12
measure: Generalized Anxiety Disorder (GAD7)
timeFrame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
measure: Patient Health Questionaire (PHQ9)
timeFrame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
Secondary outcomes:
measure: Hidradenitis Suppurativa Quality of Life Index (HiSQOL)
timeFrame: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Dermatology Clinic
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Vivian Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.