Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Cognitive-behavioral couple therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment package will include the following: information about the nature of CBCT; education about PVD and how it impacts on sexuality; education concerning a multifactorial view of pain; relaxation techniques; vaginal dilatation exercises; cognitive restructuring exercises (replacing distorted or irrational beliefs about pain and sexuality by more realistic ones); distraction techniques focusing on sexual imagery; expansion of the sexual repertoire; and exercises to improve pain and sexuality-relevant couple interactions (e.g., communication skills training, modification of maladaptive partner responses to pain, emotional disclosure and validation exercises).
Other intervention name(s): Cognitive Behavioral Pain and Sex Therapy (CBPST)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment