Back to resultsIntegrated Mindfulness for Provoked Vestibulodynia (IMPROVED)
Primary Purpose
Provoked Vestibulodynia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Psychoeducational Treatment
Waitlist control
Sponsored by
About this trial
This is an interventional treatment trial for Provoked Vestibulodynia focused on measuring provoked vestibulodynia, dyspareunia, vulvodynia, mindfulness, cognitive behavioural therapy
Eligibility Criteria
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.
Sites / Locations
- British Columbia Centre for Sexual Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate treatment
Waitlist Control- delayed treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Sexual Distress
The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)
Full Information
NCT ID
NCT01704443
First Posted
August 24, 2012
Last Updated
May 30, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01704443
Brief Title
Integrated Mindfulness for Provoked Vestibulodynia
Acronym
IMPROVED
Official Title
Integrated Mindfulness for Provoked Vestibulodynia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Vestibulodynia
Keywords
provoked vestibulodynia, dyspareunia, vulvodynia, mindfulness, cognitive behavioural therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control- delayed treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Psychoeducational Treatment
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Waitlist control
Intervention Description
No treatment will be provided during the 8 week Waitlist control period
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
one week pre-treatment to one week post treatment
Title
Long-term pain intensity
Description
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
Time Frame
One week pre-treatment to 6 months post preatment
Secondary Outcome Measure Information:
Title
Sexual Distress
Description
The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)
Time Frame
One week pre-treatment, one week post treatment and 6-months follow up
Other Pre-specified Outcome Measures:
Title
Pain Catastrophising
Description
The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
Time Frame
one week pre-treatment, one week post treatment and 6-months follow-up
Title
Pain hypervigilance
Description
The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)
Time Frame
one week pre-treatment, one week post treatment and 6-months follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A Brotto, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Centre for Sexual Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.obgyn.ubc.ca/SexualHealth/
Description
Related Info
Learn more about this trial
Integrated Mindfulness for Provoked Vestibulodynia
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