Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Not Applicable

Completed

• Conditions: Vulvar Vestibulitis
• Interventions: Behavioral: cognitive-behavioural therapy; Behavioral: physical therapy

• Registration Number: NCT02494934
• Lead Sponsor: Queen's University

Brief Summary

The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

Detailed Description

Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• fluent in English
• vulvar pain with attempted vaginal penetration for at least 6 months
• pain limited to vulvar vestibule during cotton swab test

Exclusion Criteria

• other serious medical, psychiatric, or other pain conditions
• generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally)
• current pregnancy, breastfeeding, or being less than 6 months postpartum
• unwillingness to abstain from other treatments for their PVD pain during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioural therapy	cognitive-behavioural therapy	Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.
physical therapy	physical therapy	Eight sessions of physical therapy targeting the pelvic floor muscles.

Primary Outcome Measures

Name	Time	Method
change from baseline in pain with sexual intercourse at 12 weeks	Baseline, 12 weeks	measured on an 11-point numerical rating scale