NCT02919813|CompletedResults
M-gCBT for Women With Provoked Localized Vulvodynia
Mindfulness-Based Group Cognitive Behavior Therapy for Women With Provoked Localized Vulvodynia: A Randomized Pilot Study
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Sponsor study identifier
interventional
31
1 country
1
Study Start
December 16, 2015
Actual (reported)Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2015
Actual (reported)July 19, 2016
Actual (reported)September 29, 2016
Actual (reported)September 30, 2017
Actual (reported)September 30, 2017
Actual (reported)December 30, 2019
Actual (reported)Tampon Test
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.
Change from time of enrollment until 6 months after study
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
Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) 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.
Mindfulness Based Group Cognitive Behavior Therapy 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.
Oregon Health and Science University
Portland, Oregon, 97239, United States
Catherine Leclair, MD
Oregon Health and Science University
31 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2016
First Posted
September 29, 2016
Study Start
December 16, 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)Last Updated
May 6, 2022
Results First Posted
December 30, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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