Integrated Mindfulness for Provoked Vestibulodynia

Study Overview
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Brief Summary
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This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.

Official Title
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Integrated Mindfulness for Provoked Vestibulodynia

Conditions
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Provoked Vestibulodynia

Intervention / Treatment
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* Behavioral: Group Psychoeducational Treatment
* Other: Waitlist control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be a patient at the British Columbia Centre for Sexual Medicine diagnosis of provoked vestibulodynia (PVD) 19 years of age or older premenopausal fluent in English Exclusion Criteria: not at patient at the BC Centre for Sexual Medicine unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain being uncomfortable and unwilling to participate in a group setting.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment<br>Women in the Immediate treatment arm will receive the Group Psychoeducational treatment in the next available group. There will be 8-9 womenper group and each session will be 2.25 hours in duration and there will be 4, bi-weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain. | Behavioral: Group Psychoeducational Treatment<br>* The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain. Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks)<br>|
| Experimental: Waitlist Control- delayed treatment<br>Women in the Waitlist Control arm will receive no treatment for a period of approximately 8 weeks. After the waitlist period they will receive the same Group Psychoeducational treatment as the participants in the immediate treatment arm of the study. | Other: Waitlist control<br>* No treatment will be provided during the 8 week Waitlist control period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch. | one week pre-treatment to one week post treatment | 
| Long-term pain intensity | Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch | One week pre-treatment to 6 months post preatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Distress | The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008) | One week pre-treatment, one week post treatment and 6-months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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provoked vestibulodynia, dyspareunia, vulvodynia, mindfulness, cognitive behavioural therapy