Integrated Mindfulness for Provoked Vestibulodynia

NCT01704443 | Completed

• 1 other identifier: H08-00885
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Provoked Vestibulodynia

Keywords

provoked vestibulodynia; dyspareunia; vulvodynia; mindfulness; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  one week pre-treatment to one week post treatment

• 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

  One week pre-treatment to 6 months post preatment

Secondary Outcomes (1)

• Sexual Distress

  One week pre-treatment, one week post treatment and 6-months follow up

Other Outcomes (2)

• Pain Catastrophising

  one week pre-treatment, one week post treatment and 6-months follow-up

• Pain hypervigilance

  one week pre-treatment, one week post treatment and 6-months follow-up

Study Arms (2)

Immediate treatment

EXPERIMENTAL

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

Waitlist Control- delayed treatment

EXPERIMENTAL

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

Interventions

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)

Immediate treatment

Waitlist control OTHER

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

Waitlist Control- delayed treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be a patient at the British Columbia Centre for Sexual Medicine
• diagnosis of provoked vestibulodynia (PVD)
• years of age or older
• premenopausal
• fluent in English

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dyspareunia; Vulvodynia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vulvar Diseases

Study Officials

• Lori A Brotto, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: October 11, 2012
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2013
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

CA (1)