Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)

University of British Columbia

Status: Completed

Conditions: Provoked Vestibulodynia

Treatments: Other: Waitlist control; Behavioral: Group Psychoeducational Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01704443

H08-00885

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Immediate treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Group Psychoeducational Treatment

Waitlist Control- delayed treatment

Experimental group

Description:

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.

Treatment:

Other: Waitlist control