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Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704443
First Posted: October 11, 2012
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Mindfulness for Provoked Vestibulodynia

Resource links provided by NLM:


Further study details as provided by Lori Brotto, University of British Columbia:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 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 [ Time Frame: 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:
  • Sexual Distress [ Time Frame: 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)


Other Outcome Measures:
  • Pain Catastrophising [ Time Frame: one week pre-treatment, one week post treatment and 6-months follow-up ]
    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 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lori Brotto, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01704443     History of Changes
Other Study ID Numbers: H08-00885
First Submitted: August 24, 2012
First Posted: October 11, 2012
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Lori Brotto, University of British Columbia:
provoked vestibulodynia
dyspareunia
vulvodynia
mindfulness
cognitive behavioural therapy

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis