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Completed

NCT Number: NCT01704443

Integrated Mindfulness for Provoked Vestibulodynia

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.

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Key information

Conditions

Provoked Vestibulodynia Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Psychoeducational Treatment

Behavioral

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)

Waitlist Control

Other

No treatment will be provided during the 8 week Waitlist control period

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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 outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: IMPROVED

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Oct 11, 2012
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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