Integrated Mindfulness for Provoked Vestibulodynia - Full Text View

Purpose

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.

Condition	Intervention
Provoked Vestibulodynia	Behavioral: Group Psychoeducational Treatment Other: Waitlist control

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Integrated Mindfulness for Provoked Vestibulodynia

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Pain intensity [ Time Frame: one week pre-treatment to one week post treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: One week pre-treatment to 6 months post preatment ] [ Designated as safety issue: No ]
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 [ Time Frame: One week pre-treatment, one week post treatment and 6-months follow up ] [ Designated as safety issue: No ]
The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)

Other Outcome Measures:

Pain Catastrophising [ Time Frame: one week pre-treatment, one week post treatment and 6-months follow-up ] [ Designated as safety issue: No ]
The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
Pain hypervigilance [ Time Frame: one week pre-treatment, one week post treatment and 6-months follow-up ] [ Designated as safety issue: No ]
The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)

Enrollment:	97
Study Start Date:	April 2008
Study Completion Date:	April 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704443

Locations

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

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Lori A Brotto, PhD

University of British Columbia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT01704443 History of Changes
Other Study ID Numbers:	H08-00885
Study First Received:	August 24, 2012
Last Updated:	June 3, 2013
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

provoked vestibulodynia
dyspareunia
vulvodynia
mindfulness
cognitive behavioural therapy

Additional relevant MeSH terms:

Vulvodynia
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013

Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)