Mindfulness in Hidradenitis Suppurativa

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 89 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Hidradenitis Suppurativa

Being tested

Mindfulness Based Stress reduction

Keywords

Quality of Life, Mindfulness

Medical subject headings

Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Mindfulness Based Stress reductionBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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

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

2. 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

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

3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Nov 2023
2. Study start3 Oct 2023
3. Primary completion30 Apr 2024
4. Study completion30 May 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.