Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia

Vestibulodynia Clinical Trial

Official title: Pilot Study to Assess the Efficacy of an Experimental 12-week Cognitive-behavioral Couple Therapy in the Treatment of Provoked Vestibulodynia

Status Completed

Clinical Trial Summary

The current pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.

Clinical Trial Description

Chronic pain problems involving the female reproductive system are major health concerns in women of all ages. As conditions which are poorly understood, they entail a great personal cost to patients and a significant financial cost to society. One such condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%. Despite its negative impact on psychosexual and relationship satisfaction, there has been a paucity of research to provide empirically validated treatments for afflicted couples. The proposed research draws on findings from our work focusing on the influence of romantic relationships in the experience of vulvodynia as well as on our past studies evaluating the efficacy of group cognitive-behavioral therapy for this problem. The proposed pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners. The primary research question is: Is there a significant difference between pre- and post-treatment measures of pain during intercourse? We hypothesize that CBCT will yield pain reduction from pre- to post-treatment. The secondary research question focuses on pre- and post-treatment differences in 1) the multidimensional aspects of pain, 2) sexuality outcomes, 3) psychological adjustment, 4) relationship factors, and 5) patient self-reported improvement and treatment satisfaction. We hypothesize that the CBCT will result in significantly greater improvements on all outcome measures, and that the intervention will demonstrate adequate feasibility. Results of this study may improve the health and quality of life of patients afflicted with vulvodynia by helping us further develop this intervention for future clinical trial testing. For exploratory purposes, a 3-month follow-up assessment of treatment outcomes will also be conducted.

This pilot trial addresses the urgent need for empirically validated treatments for vulvodynia, and will help refine an intervention for future clinical trial testing. Results may improve the health and quality of life of couples afflicted with this highly prevalent women's health care problem. Findings will generate information about the feasibility and preliminary efficacy of a frequently recommended intervention for PVD, counselling targeting the couple. The findings will help provide women with PVD and their partners with scientifically based treatment options and may allow them to reduce the pain experienced during intercourse, in addition to improving their sexual functioning, overall well-being, and romantic relationship. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

• NCT number: NCT01582373
• Study type: Interventional
• Source: Université de Montréal
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Completion date: December 2014