M-gCBT for Women With Provoked Localized Vulvodynia (NCT02919813) | Clinical Trial Compass
CompletedNot Applicable
M-gCBT for Women With Provoked Localized Vulvodynia
United States31 participantsStarted 2015-12-16
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Pregnancy
✕. 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).
What they're measuring
1
Tampon Test
Timeframe: Change from time of enrollment until 6 months after study