Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

NCT02494934 | Completed

• 1 other identifier: 379631
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Vulvar Vestibulitis

Outcome Measures

Primary Outcomes (1)

• change from baseline in pain with sexual intercourse at 12 weeks

  measured on an 11-point numerical rating scale

  Baseline, 12 weeks

Study Arms (2)

Cognitive-behavioural therapy

EXPERIMENTAL

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

Behavioral: cognitive-behavioural therapy

physical therapy

EXPERIMENTAL

Eight sessions of physical therapy targeting the pelvic floor muscles.

Behavioral: physical therapy

Interventions

cognitive-behavioural therapy 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.

Cognitive-behavioural therapy

physical therapy 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.

physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fluent in English
• vulvar pain with attempted vaginal penetration for at least 6 months
• pain limited to vulvar vestibule during cotton swab test

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Vulvar Vestibulitis

Interventions

Cognitive Behavioral Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Vulvitis; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Study Officials

• Caroline Pukall, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 10, 2015
• Study Start: September 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 1, 2015

Record last verified: 2015-08