Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01704443
First received: August 24, 2012
Last updated: June 3, 2013
Last verified: June 2013
  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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 20, 2014