Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Brief Title

Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Official Title

A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia

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 Type

Interventional


Primary Outcome

change from baseline in pain with sexual intercourse at 12 weeks


Condition

Vulvar Vestibulitis

Intervention

cognitive-behavioural therapy

Study Arms / Comparison Groups

 Cognitive-behavioural therapy
Description:  Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

20

Start Date

September 2009

Completion Date

April 2012

Primary Completion Date

April 2012

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Caroline Pukall, PhD, , 



Administrative Informations


NCT ID

NCT02494934

Organization ID

379631


Responsible Party

Principal Investigator

Study Sponsor

Queen's University


Study Sponsor

Caroline Pukall, PhD, Principal Investigator, Queen's University


Verification Date

August 2015