N/A
N=31
M-gCBT for Women With Provoked Localized Vulvodynia
Provoked Localized Vulvodynia
Bottom Line
View on ClinicalTrials.gov: NCT02919813 ↗Enrolled (actual)
31
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Tampon Test — -2.43; -1.88 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Group Cognitive BehaviorTherapy (Behavioral); Educational Seminars (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tampon Test |
-2.43; -1.88 | — |
| SECONDARY Sexual Distress Survey Response |
-14.53; -10.52 | — |
| SECONDARY Sexual Function Questionnaire Response |
13.33; 1.23 | — |
| SECONDARY Depression Questionnaire Response |
-5.03; -0.02 | — |
| SECONDARY Anxiety Questionnaire Response |
-3.10; -0.26 | — |
| SECONDARY Pain Catastrophizing Scale Response |
-12.24; -11.16 | — |
| SECONDARY Quality of Life Questionnaire Response |
— | — |
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.
Eligibility Criteria
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).
- 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
Data sourced from ClinicalTrials.gov (NCT02919813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.