Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)

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.

Study Overview

• Status: Completed
• Conditions: Provoked Vestibulodynia
• Intervention / Treatment: Behavioral: Group Psychoeducational Treatment; Other: Waitlist control

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • British Columbia Centre for Sexual Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate 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.	Behavioral: Group Psychoeducational Treatment; 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)
Experimental: Waitlist Control- delayed treatment; 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; No treatment will be provided during the 8 week Waitlist control period

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophising	The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).	one week pre-treatment, one week post treatment and 6-months follow-up
Pain hypervigilance	The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)	one week pre-treatment, one week post treatment and 6-months follow-up

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: mindfulness; cognitive behavioural therapy; dyspareunia; provoked vestibulodynia; vulvodynia
• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvitis; Vulvodynia; Vulvar Vestibulitis
• Other Study ID Numbers: H08-00885