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M-gCBT for Women With Provoked Localized Vulvodynia

NCT02919813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-05-06

Study results available
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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.

Conditions

  • Provoked Localized Vulvodynia

Interventions

BEHAVIORAL

Mindfulness Based Group Cognitive BehaviorTherapy

Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain.

BEHAVIORAL

Educational Seminars

Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.

Sponsors & Collaborators

  • Medical Research Foundation, Oregon

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Catherine Leclair, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-16
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919813 on ClinicalTrials.gov