Back to resultsM-gCBT for Women With Provoked Localized Vulvodynia
Primary Purpose
Provoked Localized Vulvodynia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Group Cognitive BehaviorTherapy
Educational Seminars
Sponsored by
About this trial
This is an interventional supportive care trial for Provoked Localized Vulvodynia focused on measuring mindfulness group therapy, vulvodynia, vulvar pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
M-gCBT Group
Educational Seminars
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sexual Distress Survey Response
Change from baseline in sexual distress at 6 months. Participants will complete a Female Sexual Distress Scale (FSDS) survey to rate their feelings associated with sexual activities; range 0 (better outcome) - 52 (worse outcome). The FSDS surveys will be completed at baseline and 6 months follow up. A negative change in FSDS score from baseline indicates less sexual distress over time (better outcome) and a positive change in FSDS score from baseline indicates more sexual distress over time (worse outcome).
Sexual Function Questionnaire Response
Change from baseline in sexual function at 6 months. Participants will complete a Female Sexual Function Index (FSFI) survey which asks questions about participants sexual feelings over the past 4 weeks; range 2 (worse outcome) - 95 (better outcome). The FSFI surveys will be completed at baseline and 6 months follow up. A negative change in FSFI score from baseline indicates less sexual function over time (worse outcome) and a positive change in FSFI score from baseline indicates more sexual function over time (better outcome).
Depression Questionnaire Response
Change from baseline in depression at 6 months. Participants will complete the Beck Depression Inventory (BDI-PC) questionnaire, which consists of 21 groups of statements where participants selects which statement best describes how they have been feeling during the past 2 weeks. Total score = sum of 21 statement subscales; range 0 (better outcome) - 63 (worse outcome). The BDI-PC surveys will be completed at baseline and 6 months follow up. A negative change in BDI-PC score from baseline indicates less depression over time (better outcome) and a positive change in BDI-PC score from baseline indicates more depression over time (worse outcome).
Anxiety Questionnaire Response
Change from baseline in anxiety at 6 months. Participants will complete the General Anxiety Disorder-7 (GAD-7) scale questionnaire. The GAD-7 consists of 7 problems where participants rate how often they have been bothered by those problems during the past 2 weeks. Total score = sum of 7 subscales; range 0 (better outcome) - 21 (worse outcome). The GAD-7 surveys will be completed at baseline and 6 months follow up. A negative change in GAD-7 score from baseline indicates less anxiety over time (better outcome) and a positive change in GAD-7 score from baseline indicates more anxiety over time (worse outcome).
Pain Catastrophizing Scale Response
Change from baseline in pain catastrophizing at 6 months. 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. Total score = sum of 13 statement subscales; range 0 (better outcome) - 52 (worse outcome). The pain catastrophizing surveys will be completed at baseline and 6 months follow up. A negative change in score from baseline indicates less pain catastrophizing over time (better outcome) and a positive change in score from baseline indicates more pain catastrophizing over time (worse outcome).
Quality of Life Questionnaire Response
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.
Full Information
NCT ID
NCT02919813
First Posted
July 19, 2016
Last Updated
May 4, 2022
Sponsor
Oregon Health and Science University
Collaborators
Medical Research Foundation, Oregon
1. Study Identification
Unique Protocol Identification Number
NCT02919813
Brief Title
M-gCBT for Women With Provoked Localized Vulvodynia
Official Title
Mindfulness-Based Group Cognitive Behavior Therapy for Women With Provoked Localized Vulvodynia: A Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Medical Research Foundation, Oregon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Localized Vulvodynia
Keywords
mindfulness group therapy, vulvodynia, vulvar pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M-gCBT Group
Arm Type
Active Comparator
Arm Description
Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT Group) is a type of counseling that teaches women to have more control over their pain.
Arm Title
Educational Seminars
Arm Type
Active Comparator
Arm Description
Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Group Cognitive BehaviorTherapy
Other Intervention Name(s)
M-gCBT
Intervention Description
Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain.
Intervention Type
Behavioral
Intervention Name(s)
Educational Seminars
Intervention Description
Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Primary Outcome Measure Information:
Title
Tampon Test
Description
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.
Time Frame
Change from time of enrollment until 6 months after study
Secondary Outcome Measure Information:
Title
Sexual Distress Survey Response
Description
Change from baseline in sexual distress at 6 months. Participants will complete a Female Sexual Distress Scale (FSDS) survey to rate their feelings associated with sexual activities; range 0 (better outcome) - 52 (worse outcome). The FSDS surveys will be completed at baseline and 6 months follow up. A negative change in FSDS score from baseline indicates less sexual distress over time (better outcome) and a positive change in FSDS score from baseline indicates more sexual distress over time (worse outcome).
Time Frame
Change from time of enrollment until 6 months after study
Title
Sexual Function Questionnaire Response
Description
Change from baseline in sexual function at 6 months. Participants will complete a Female Sexual Function Index (FSFI) survey which asks questions about participants sexual feelings over the past 4 weeks; range 2 (worse outcome) - 95 (better outcome). The FSFI surveys will be completed at baseline and 6 months follow up. A negative change in FSFI score from baseline indicates less sexual function over time (worse outcome) and a positive change in FSFI score from baseline indicates more sexual function over time (better outcome).
Time Frame
Change from time of enrollment until 6 months after study
Title
Depression Questionnaire Response
Description
Change from baseline in depression at 6 months. Participants will complete the Beck Depression Inventory (BDI-PC) questionnaire, which consists of 21 groups of statements where participants selects which statement best describes how they have been feeling during the past 2 weeks. Total score = sum of 21 statement subscales; range 0 (better outcome) - 63 (worse outcome). The BDI-PC surveys will be completed at baseline and 6 months follow up. A negative change in BDI-PC score from baseline indicates less depression over time (better outcome) and a positive change in BDI-PC score from baseline indicates more depression over time (worse outcome).
Time Frame
Change from time of enrollment until 6 months after study
Title
Anxiety Questionnaire Response
Description
Change from baseline in anxiety at 6 months. Participants will complete the General Anxiety Disorder-7 (GAD-7) scale questionnaire. The GAD-7 consists of 7 problems where participants rate how often they have been bothered by those problems during the past 2 weeks. Total score = sum of 7 subscales; range 0 (better outcome) - 21 (worse outcome). The GAD-7 surveys will be completed at baseline and 6 months follow up. A negative change in GAD-7 score from baseline indicates less anxiety over time (better outcome) and a positive change in GAD-7 score from baseline indicates more anxiety over time (worse outcome).
Time Frame
Change from time of enrollment until 6 months after study
Title
Pain Catastrophizing Scale Response
Description
Change from baseline in pain catastrophizing at 6 months. 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. Total score = sum of 13 statement subscales; range 0 (better outcome) - 52 (worse outcome). The pain catastrophizing surveys will be completed at baseline and 6 months follow up. A negative change in score from baseline indicates less pain catastrophizing over time (better outcome) and a positive change in score from baseline indicates more pain catastrophizing over time (worse outcome).
Time Frame
Change from time of enrollment until 6 months after study
Title
Quality of Life Questionnaire Response
Description
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.
Time Frame
Change from end of study until 6 months after study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Leclair, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
M-gCBT for Women With Provoked Localized Vulvodynia
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