Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Study Overview
=================
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).

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

Conditions
-----------------
Vulvar Vestibulitis

Intervention / Treatment
-----------------
* Behavioral: cognitive-behavioural therapy
* Behavioral: physical therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioural therapy<br>Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions. | Behavioral: cognitive-behavioural therapy<br>* The CBT program was adapted from a previously used group CBT program and included the following procedures: (1) education about PVD; (2) collaborative re-conceptualization of PVD as a multi-factorial pain condition; (3) desensitization exercises; (4) diaphragmatic breathing and other relaxation techniques; (5) discussion about and techniques for increasing sexual desire and arousal; (6) sexual communication skills training; (7) instructions on carrying out PFM exercises; (8) instructions on the use of silicone vaginal dilators to do progressive vaginal penetration activities at home; and (9) informal and formal cognitive restructuring techniques and the use of coping self-statements.<br>|
| Experimental: physical therapy<br>Eight sessions of physical therapy targeting the pelvic floor muscles. | Behavioral: physical therapy<br>* The PT treatment protocol included the following procedures: (1) education about PVD; (2) targeted PFM exercises focused on contraction and relaxation including in-session practice and feedback; (3) manual techniques; (4) surface electromyographic biofeedback (sEMG); (5) progressive vaginal penetration activities through the use of four silicone vaginal dilators of varied diameter; (6) stretches of the hip muscles; (7) deep breathing and global body relaxation exercises; and (8) additional methods of managing pain and counseling about different sexual positions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in pain with sexual intercourse at 12 weeks | measured on an 11-point numerical rating scale | Baseline, 12 weeks |