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M-gCBT for Women With Provoked Localized Vulvodynia

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ClinicalTrials.gov Identifier: NCT02919813
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Medical Research Foundation, Oregon
Information provided by (Responsible Party):
Catherine Leclair, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Provoked Localized Vulvodynia Behavioral: Mindfulness Based Group Cognitive BehaviorTherapy Behavioral: Educational Seminars Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness-Based Group Cognitive Behavior Therapy for Women With Provoked Localized Vulvodynia: A Randomized Pilot Study
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: M-gCBT

Active Comparator: Educational Seminars
Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Behavioral: Educational Seminars
Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.




Primary Outcome Measures :
  1. Tampon Test [ Time Frame: Change from time of enrollment until 6 months after study ]
    The reduction in pain measured by the Tampon Test tested throughout the intervention phase. 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, weekly for 8 weeks and at 3 months and 6 months follow up.


Secondary Outcome Measures :
  1. Sexual Distress Survey Response [ Time Frame: Change from time of enrollment until 6 months after study ]
    Improvement in sexual function from baseline survey. Participants will complete a Female Sexual Distress Scale (FSDS) survey to rate their feelings associated with sexual activities. Survey questions are on a number scale of 0 (Never) to 4 (Always). The FSDS surveys will be completed at baseline, end of treatment, and at 3 months and 6 months follow up.

  2. Sexual Function Questionnaire Response [ Time Frame: Change from time of enrollment until 6 months after study ]
    Improvement in sexual function from baseline questionnaire. Participants will complete a Female Sexual Function Index (FSFI) survey which asks questions about participants sexual feelings over the past 4 weeks. Responses to FSFI questions are assigned a number value ranging from 0 (No sexual activity, if applicable) to 5 (Very satisfied). Domain scores and an overall score will be derived from those values using a computational formula in order to obtain participant scores for the FSFI. The FSFI surveys will be completed at baseline, end of treatment, and at 3 months and 6 months follow up.

  3. Depression Questionnaire Response [ Time Frame: Change from time of enrollment until 6 months after study ]
    Improvement in depression from baseline questionnaire. Participants will complete the Beck Depression Inventory (BDI-PC) questionnaire. The BDI-PC consists of 21 groups of statements where participants selects which statement best describes how they have been feeling during the past 2 weeks. The BDI-PC questionnaire will be completed at baseline, end of treatment, and at 3 months and 6 months follow up.

  4. Anxiety Questionnaire Response [ Time Frame: Change from time of enrollment until 6 months after study ]
    Improvement in anxiety from baseline questionnaire. Participants will complete the General Anxiety Disorder-7 (GAD-7) scale questionnaire. The GAD-7 consists of 7 problems where participants rate on a scale of 0 (Not at all) to 3 (Nearly every day) how often they have been bothered by those problems during the past 2 weeks. The GAD-7 questionnaire will be completed at baseline, end of treatment, and at 3 months and 6 months follow up.

  5. Pain Catastrophizing Scale Response [ Time Frame: Change from time of enrollment until 6 months after study ]
    Improvement in pain catastrophizing from baseline survey. Participants will complete the Pain Catastrophizing Scale survey. The survey consists of thirteen statements describing different thoughts and feelings that may be associated with pain. Participants are asked to rate the degree to which they have these thoughts/feelings expressed in each statement on a scale of 0 (Not at all) to 4 (All the time). The survey will be completed at baseline, end of treatment, and at 3 months and 6 months follow up.

  6. Quality of Life Questionnaire Response [ Time Frame: Change from end of study until 6 months after study ]
    Perceived treatment improvement and satisfaction in quality of life questionnaire. Questionnaires for quality of life at end of group intervention and at 3 months and 6 months follow up.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919813


Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Medical Research Foundation, Oregon
Investigators
Principal Investigator: Catherine Leclair, MD Oregon Health and Science University

Responsible Party: Catherine Leclair, MD, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02919813     History of Changes
Other Study ID Numbers: OHSU IRB 15221
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Catherine Leclair, MD, Oregon Health and Science University:
mindfulness group therapy
vulvodynia
vulvar pain

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female