Trial Outcomes & Findings for M-gCBT for Women With Provoked Localized Vulvodynia (NCT NCT02919813)
NCT ID: NCT02919813
Last Updated: 2022-05-06
Results Overview
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.
COMPLETED
NA
31 participants
Change from time of enrollment until 6 months after study
2022-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
M-gCBT for Women With Provoked Localized Vulvodynia
Baseline characteristics by cohort
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
BMI
|
22.5 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
22.1 kg/m^2
STANDARD_DEVIATION 3.2 • n=7 Participants
|
22.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Relationship status
Partnered
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Relationship status
Not partnered
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Previous physical therapy
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Previous counseling
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from time of enrollment until 6 months after studyThe 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.
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Tampon Test
|
-2.43 units on a scale
Interval -3.41 to -1.46
|
-1.88 units on a scale
Interval -2.83 to -0.92
|
SECONDARY outcome
Timeframe: Change from time of enrollment until 6 months after studyChange 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).
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Sexual Distress Survey Response
|
-14.53 score on a scale
Interval -20.09 to -8.98
|
-10.52 score on a scale
Interval -15.39 to -5.65
|
SECONDARY outcome
Timeframe: Change from time of enrollment until 6 months after studyChange 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).
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Sexual Function Questionnaire Response
|
13.33 score on a scale
Interval 4.14 to 22.52
|
1.23 score on a scale
Interval -6.4 to 8.87
|
SECONDARY outcome
Timeframe: Change from time of enrollment until 6 months after studyChange 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).
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Depression Questionnaire Response
|
-5.03 score on a scale
Interval -8.49 to -1.56
|
-0.02 score on a scale
Interval -3.27 to 3.23
|
SECONDARY outcome
Timeframe: Change from time of enrollment until 6 months after studyChange 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).
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Anxiety Questionnaire Response
|
-3.10 score on a scale
Interval -4.89 to -1.31
|
-0.26 score on a scale
Interval -1.86 to 1.33
|
SECONDARY outcome
Timeframe: Change from time of enrollment until 6 months after studyChange 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).
Outcome measures
| Measure |
M-gCBT Group
n=14 Participants
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.
|
Educational Seminars
n=17 Participants
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.
|
|---|---|---|
|
Pain Catastrophizing Scale Response
|
-12.24 score on a scale
Interval -17.37 to -7.11
|
-11.16 score on a scale
Interval -15.67 to -6.66
|
SECONDARY outcome
Timeframe: Change from end of study until 6 months after studyPopulation: Outcome was not analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
M-gCBT Group
Educational Seminars
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
OB/Gyn Regulatory Specialist
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place