Mindfulness-Based Group Cognitive Behavior Therapy for Women With Provoked Localized Vulvodynia: A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Tampon Test
研究概览
简要总结
The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions, including chronic pain conditions. The investigators wish to see if participation in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than education alone. Both techniques use a group setting including other women with PLV. "Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia" is a study designed to learn more about the use of mindfulness based group cognitive behavior therapy for PLV pain and anxiety over education alone. Participants will be randomized to one of two groups: mindfulness based cognitive behavior therapy or group education seminars.
详细描述
M-gCBT is a type of counseling that teaches women to have more control over their pain. Educational seminars teach women about the different aspects of PLV that affect emotional and physical health. Both groups will be given a binder containing course material at the first session and homework at each session that you will be asked to complete. The group education seminars will include an informational video clip reviewing an aspect of PLV and sexuality and will be followed by a group discussion facilitated by an instructor. Each session will involve a teacher and a small group of 6 to 12 women with PLV. Additionally, women in both groups will be asked to perform a weekly test to measure pain and to complete a daily diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reported dyspareunia for at least 6 months in non-pregnant, healthy women over aged 18-45 years old meeting Friedrich's criteria for PLV.51
- •Qtip Test51-52, 54 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock), and have received a Qtip Test score of verbal ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum.
- •Ability to insert a regular Tampax® tampon
- •Baseline tampon test pain score ≥80mm
- •Phone access
- •Lives within 60 miles with reliable transportation
排除标准
- •Active counseling or mindfulness training (within 6 months of study)
- •Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc).
- •Impaired cognition or disruptive behavior not conducive to group dynamic
- •Planned long term travel or surgery during study period
- •Unable or unwilling to complete baseline assessments or agree to be randomized.
- •Axis 2 diagnosis, chronic substance abuse, suicidality or disruptive to group dynamic
- •Non-English speaking
结局指标
主要结局
Tampon Test
时间窗: Change from time of enrollment until 6 months after study
The change from baseline in pain measured by the Tampon Test at 6 months. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.
次要结局
- Sexual Distress Survey Response(Change from time of enrollment until 6 months after study)
- Sexual Function Questionnaire Response(Change from time of enrollment until 6 months after study)
- Depression Questionnaire Response(Change from time of enrollment until 6 months after study)
- Anxiety Questionnaire Response(Change from time of enrollment until 6 months after study)
- Pain Catastrophizing Scale Response(Change from time of enrollment until 6 months after study)
- Quality of Life Questionnaire Response(Change from end of study until 6 months after study)
研究者
Catherine M Leclair, MD
Associate Professor
Oregon Health and Science University