M-gCBT for Women With Provoked Localized Vulvodynia

NCT02919813 | Completed Results

• 1 other identifier: OHSU IRB 15221
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Provoked Localized Vulvodynia

Keywords

mindfulness group therapy; vulvodynia; vulvar pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

M-gCBT Group

ACTIVE COMPARATOR

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

Behavioral: Mindfulness Based Group Cognitive BehaviorTherapy

Educational Seminars

ACTIVE COMPARATOR

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

Behavioral: Educational Seminars

Interventions

Mindfulness Based Group Cognitive BehaviorTherapy BEHAVIORAL

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

Also known as: M-gCBT

M-gCBT Group

Educational Seminars BEHAVIORAL

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

Educational Seminars

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: OB/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Catherine Leclair, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 29, 2016
• Study Start: December 16, 2015
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: May 6, 2022
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)