M-gCBT for Women With Provoked Localized Vulvodynia

NCT ID: NCT02919813

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-16
• Study Completion Date: 2017-09-30

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.

Conditions

Provoked Localized Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

M-gCBT Group

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

Group Type: ACTIVE_COMPARATOR

Mindfulness Based Group Cognitive BehaviorTherapy

Intervention Type: BEHAVIORAL

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

Educational Seminars

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

Group Type: ACTIVE_COMPARATOR

Educational Seminars

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Educational Seminars

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

Intervention Type: BEHAVIORAL

Other Intervention Names

M-gCBT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Foundation, Oregon

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Catherine M Leclair, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Leclair, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OHSU IRB 15221

Identifier Type: -

Identifier Source: org_study_id