Sophie Bergeron, PhD (left), & Natalie Ora Rosen, PhD (right)A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: A randomized clinical trial (2004-2013)
Vulvodynia is a complex, multi-factorial chronic pain syndrome which is associated with significant distress and interpersonal. Vulvar vestibulitis and dyspareunia are two common, although not well-understood clinical components or sub-types of vulvodynia. Chronic vulvar pain is experienced by, according to recent surveys, about 10-15% of the female population between 18 and 80. Pathophysiologic findings have not been convincing for the role of any specific antibody or etiological mechanism, although several have been proposed including aberrant somatosensory processing in the peripheral or central inflammatory process. The epidemiology and predictors of vulvodynia have similarly not been well- articulated in the literature. One study suggested that the disorder may be largely limited to white, middle-aged women, although sampling and data gathering limitations cloud the assessment of these findings. Thirdly, many centers have begun emphasizing surgical treatments for vulvar vestibulitis, although these approach is rejected by about 1/3 of women at the outset. The vestibulectomy procedure also leads to definite worsening of the condition in about 10% of cases. This grant will propose to examine efficacy, outcomes and cost-effectiveness associated with four non-surgical interventions for vulvodynia. In general, the women’s Health Research Section of RWJMS is committed to offering minimally- invasive services and treatments to a broad diversity of women in the central northeast region. Our previous experience and that of our Co-PI’s make our site uniquely well-prepared to offer a broad range of dissemination and educational experiences, both locally and nationally, in the final years of the grant cycle. We plan to arrange and host an international consensus conference (something we have done twice recently in other areas of relevance), and to disseminate findings obtained from this and similar conferences broadly. We will also disseminate any questionnaires and treatment manuals developed in the context of this grant via website or other appropriate electronic or non-electronic form. We will develop patient education and public information materials, which will also be distributed in the most accessible and least costly form. Our ultimate goal is to share findings from this and related research with the broadest cross-spectrum of women that we can.
A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: A randomized clinical trial (2013-2016)
Chronic pain problems involving the female reproductive system are major health concerns for all women. Poorly understood, they entail great personal and financial cost. 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 is little research examining empirically-tested treatments for afflicted couples. The proposed research builds on findings from our work focusing on the impact of relational factors on vulvodynia, and our previous research evaluating the efficacy of group cognitive-behavioral therapy for this problem. This two-centre randomized clinical trial aims to assess the efficacy of a novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in comparison to one of the most commonly prescribed first-line medical interventions, topical lidocaine. Primary research question: Is there a significant difference between the two treatments on women’s pain during intercourse post-treatment? Based on our previous work and existing literature, we hypothesize that CBCT will yield significantly greater pain reduction post-treatment than lidocaine. Secondary research questions will assess for significant differences between the two treatments post-treatment and at 6-month follow-up on multidimensional aspects of pain using the McGill Pain Questionnaire, women and partners’ sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression, catastrophizing, self-efficacy, attributions, and quality of life), relationship factors (partner responses and dyadic adjustment), and self-reported improvement and treatment satisfaction. We hypothesize that CBCT will show significantly greater improvements on all outcome measures compared to lidocaine. Results of this study will improve the health and quality of life of patients with vulvodynia by rigorously testing the efficacy of a novel couples treatment.