Integrated Mindfulness for Provoked Vestibulodynia

Not Applicable

Completed

• Conditions: Provoked Vestibulodynia
• Interventions: Behavioral: Group Psychoeducational Treatment; Other: Waitlist control

• Registration Number: NCT01704443
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Primary Completion: 2012-11
• Study Completion: 2013-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate treatment	Group Psychoeducational Treatment	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.
Waitlist Control- delayed treatment	Waitlist control	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	one week pre-treatment to one week post treatment	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.
Long-term pain intensity	One week pre-treatment to 6 months post preatment	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

British Columbia Centre for Sexual Medicine; 🇨🇦 Vancouver, British Columbia, Canada