Mindfulness in Hidradenitis Suppurativa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Dermatology Quality of Life Index (DLQI scores)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Dermatology Quality of Life Index (DLQI scores)
时间窗: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12
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
Generalized Anxiety Disorder (GAD7)
时间窗: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
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
Patient Health Questionaire (PHQ9)
时间窗: Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12.
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
次要结局
- 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.)