Provoked Localized Vulvodynia
Conditions
Keywords
mindfulness group therapy, vulvodynia, vulvar pain
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALEducational Seminars
Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Sponsors
Medical Research Foundation, Oregon
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tampon Test | Change from time of enrollment until 6 months after study | 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
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function Questionnaire Response | Change from time of enrollment until 6 months after study | 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 time of enrollment until 6 months after study | 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). |
| Sexual Distress Survey Response | Change from time of enrollment until 6 months after study | 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). |
| Pain Catastrophizing Scale Response | Change from time of enrollment until 6 months after study | 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 | 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. |
| Anxiety Questionnaire Response | Change from time of enrollment until 6 months after study | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 14 |
| Educational Seminars Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Educational Seminars: Educational seminars teach women about the different aspects of PLV that affect emotional and physical health. | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | Educational Seminars | Total | M-gCBT Group |
|---|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 6.1 | 31.6 years STANDARD_DEVIATION 6.6 | 34.4 years STANDARD_DEVIATION 6.2 |
| BMI | 22.1 kg/m^2 STANDARD_DEVIATION 3.2 | 22.3 kg/m^2 STANDARD_DEVIATION 4.2 | 22.5 kg/m^2 STANDARD_DEVIATION 5.3 |
| Previous counseling | 7 Participants | 10 Participants | 3 Participants |
| Previous physical therapy | 15 Participants | 25 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 16 Participants | 27 Participants | 11 Participants |
| Region of Enrollment United States | 17 Participants | 31 Participants | 14 Participants |
| Relationship status Not partnered | 4 Participants | 6 Participants | 2 Participants |
| Relationship status Partnered | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Female | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Tampon Test | -2.43 units on a scale |
| Educational Seminars | Tampon Test | -1.88 units on a scale |
Secondary
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).
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Anxiety Questionnaire Response | -3.10 score on a scale |
| Educational Seminars | Anxiety Questionnaire Response | -0.26 score on a scale |
Secondary
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).
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Depression Questionnaire Response | -5.03 score on a scale |
| Educational Seminars | Depression Questionnaire Response | -0.02 score on a scale |
Secondary
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).
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Pain Catastrophizing Scale Response | -12.24 score on a scale |
| Educational Seminars | Pain Catastrophizing Scale Response | -11.16 score on a scale |
Secondary
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.
Time frame: Change from end of study until 6 months after study
Population: Outcome was not analyzed.
Secondary
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).
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Sexual Distress Survey Response | -14.53 score on a scale |
| Educational Seminars | Sexual Distress Survey Response | -10.52 score on a scale |
Secondary
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).
Time frame: Change from time of enrollment until 6 months after study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-gCBT Group | Sexual Function Questionnaire Response | 13.33 score on a scale |
| Educational Seminars | Sexual Function Questionnaire Response | 1.23 score on a scale |