Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

NCT ID: NCT02494934

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-04-30

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).

Conditions

Vulvar Vestibulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive-behavioural therapy

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

Group Type: EXPERIMENTAL

cognitive-behavioural therapy

Intervention Type: BEHAVIORAL

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.

physical therapy

Eight sessions of physical therapy targeting the pelvic floor muscles.

Group Type: EXPERIMENTAL

physical therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Caroline Pukall

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Pukall, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Other Identifiers

379631

Identifier Type: -

Identifier Source: org_study_id