Clinical trial NCT02919813: M-gCBT for Women With Provoked Localized Vulvodynia
Official title: Mindfulness-Based Group Cognitive Behavior Therapy for Women With Provoked Localized Vulvodynia: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Localized Vulvodynia
Keywords: mindfulness group therapy
vulvodynia
vulvar pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Medical Research Foundation, Oregon
First posted: 2016-09-29
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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.
3. Ability to insert a regular Tampax® tampon
4. Baseline tampon test pain score ≥80mm
5. Phone access
6. Lives within 60 miles with reliable transportation

Exclusion Criteria:

1. Pregnancy
2. Active counseling or mindfulness training (within 6 months of study)
3. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc).
4. Impaired cognition or disruptive behavior not conducive to group dynamic
5. Planned long term travel or surgery during study period
6. Unable or unwilling to complete baseline assessments or agree to be randomized.
7. Axis 2 diagnosis, chronic substance abuse, suicidality or disruptive to group dynamic
8. Non-English speaking

Primary outcomes:
measure: Tampon Test
timeFrame: Change from time of enrollment until 6 months after study
Secondary outcomes:
measure: Sexual Distress Survey Response
timeFrame: Change from time of enrollment until 6 months after study
measure: Sexual Function Questionnaire Response
timeFrame: Change from time of enrollment until 6 months after study
measure: Depression Questionnaire Response
timeFrame: Change from time of enrollment until 6 months after study
measure: Anxiety Questionnaire Response
timeFrame: Change from time of enrollment until 6 months after study
measure: Pain Catastrophizing Scale Response
timeFrame: Change from time of enrollment until 6 months after study
measure: Quality of Life Questionnaire Response
timeFrame: Change from end of study until 6 months after study
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Catherine Leclair, MD
role: PRINCIPAL_INVESTIGATOR
References: