title: A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: study protocol for a randomized clinical trial.
abstract: BACKGROUND
  Provoked vestibulodynia (PVD), a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors, such as pain catastrophizing, partner responses to pain, ambivalence over emotional expression, attachment style and perceived relationship and sexual intimacy. Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes, no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention.
  
  
  METHODS
  This bi-center, randomized clinical trial is designed to examine the efficacy of cognitive-behavioral couple therapy compared to topical lidocaine. It is conducted across two Canadian university-hospital centers. Eligible women diagnosed with PVD and their partners are randomized to one of the two interventions. Evaluations are conducted using structured interviews and validated self-report measures at three time points: Pre-treatment (T1: prior to randomization), post-treatment (T2), and 6-month follow-up (T3). The primary outcome is the change in reported pain during intercourse between T1 and T2. Secondary outcomes focus on whether there are significant differences between the two treatments at T2 and T3 on (a) the multidimensional aspects of women's pain and (b) women and partners' sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression, catastrophizing, self-efficacy, and quality of life), relationship factors (partner responses and dyadic adjustment) and self-reported improvement and treatment satisfaction. In order to detect an effect size as small as 0.32 for secondary outcomes, a sample of 170 couples is being recruited (27% dropout expected). A clinically significant decrease in pain is defined as a 30% reduction.
  
  
  CONCLUSIONS
  The randomized clinical trial design is the most appropriate to examine the efficacy of cognitive-behavioral couple therapy, a recently developed and pilot-tested psychosocial intervention for couples coping with PVD, in comparison to a frequent first-line treatment option, topical lidocaine. Findings from this study will provide important information about empirically supported treatment options for PVD, and inform future treatment development and research for this patient population.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01935063; registration date: 27 August 27 2013.
authors.affiliation: Department of Psychology, Université de Montréal, 2900 Boulevard Édouard-Montpetit, Montréal H3T 1J4, Canada. serena.corsini-munt@umontreal.ca.
authors.forename: Serena
authors.initials: S
authors.lastname: Corsini-Munt
authors.forename: Sophie
authors.initials: S
authors.lastname: Bergeron
authors.forename: Natalie O
authors.initials: NO
authors.lastname: Rosen
authors.forename: Marc
authors.initials: M
authors.lastname: Steben
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Mayrand
authors.forename: Isabelle
authors.initials: I
authors.lastname: Delisle
authors.forename: Pierre
authors.initials: P
authors.lastname: McDuff
authors.forename: Leen
authors.initials: L
authors.lastname: Aerts
authors.forename: Marie
authors.initials: M
authors.lastname: Santerre-Baillargeon
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059350:Chronic Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D019546:Couples Therapy; D005260:Female; D006785:Hospitals, University; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009674:Nova Scotia; D010147:Pain Measurement; D010549:Personal Satisfaction; D011792:Quebec; D012107:Research Design; D012725:Sexual Behavior; D018454:Spouses / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D056650:Vulvodynia / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D008012:Lidocaine