Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia
Primary Purpose
Vulvar Vestibulitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive-behavioural therapy
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Vestibulitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive-behavioural therapy
physical therapy
Arm Description
Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.
Eight sessions of physical therapy targeting the pelvic floor muscles.
Outcomes
Primary Outcome Measures
change from baseline in pain with sexual intercourse at 12 weeks
measured on an 11-point numerical rating scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02494934
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Vestibulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioural therapy
Arm Type
Experimental
Arm Description
Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.
Arm Title
physical therapy
Arm Type
Experimental
Arm Description
Eight sessions of physical therapy targeting the pelvic floor muscles.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioural therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline in pain with sexual intercourse at 12 weeks
Description
measured on an 11-point numerical rating scale
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Pukall, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia
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