Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Sponsor

Queen's University (Other)

Overall Status

Completed

CT.gov ID

NCT02494934

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Vulvar Vestibulitis	Behavioral: cognitive-behavioural therapy Behavioral: physical therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive-behavioural therapy Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.	Behavioral: cognitive-behavioural therapy 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.
Experimental: physical therapy Eight sessions of physical therapy targeting the pelvic floor muscles.	Behavioral: physical therapy 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.

Arm

Intervention/Treatment

Experimental: Cognitive-behavioural therapy

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

Behavioral: cognitive-behavioural therapy

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.

Experimental: physical therapy

Eight sessions of physical therapy targeting the pelvic floor muscles.

Behavioral: physical therapy

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Queen's University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Caroline Pukall, Professor, Queen's University

ClinicalTrials.gov Identifier:

NCT02494934

Other Study ID Numbers:

379631

First Posted:

Jul 10, 2015

Last Update Posted:

Sep 1, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Vulvodynia

Vulvar Vestibulitis

Study Results

No Results Posted as of Sep 1, 2015