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

NCT ID: NCT01582373

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Vestibulodynia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive-behavioral couple therapy

The goals of CBCT are to enable participants to: (1) re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviors and couple interactions; (2) re-conceptualize PVD as a couple problem in which both members of the couple affect and are affected by the pain; (3) modify those factors associated with pain during intercourse with a view to increasing adaptive coping, for example, by increasing self-efficacy and decreasing catastrophizing, as well as decreasing pain intensity; (4) improve the quality of their sexual functioning, reduce their sexual distress and increase their sexual satisfaction; (5) consolidate skills.

Group Type: EXPERIMENTAL

Cognitive-behavioral couple therapy

Intervention Type: BEHAVIORAL

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).

Interventions

Cognitive-behavioral couple therapy

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Behavioral Pain and Sex Therapy (CBPST)

Eligibility Criteria

Inclusion Criteria

• pain during intercourse which is a) subjectively distressing, b) occurs on 80% of intercourse attempts, and c) has lasted for at least one year
• pain limited to intercourse and other activities involving pressure to the vestibule
• significant pain in one or more locations of the vestibule during the gynaecological exam, which is operationalized as a minimum average patient pain rating of 4 on a scale of 0 to 10
• having been sexually active as a couple in the last three months (intercourse, manual or oral stimulation)
• in a committed relationship for at least six months

Exclusion Criteria

• vulvar pain not clearly linked to intercourse or pressure applied to the vestibule
• presence of one of the following: a) major medical and/or psychiatric illness, b) active infection, c) deep dyspareunia, d) vaginismus (as defined by DSM-IV), e) dermatologic lesion, f) pregnancy or planning a pregnancy
• age less than 18 or greater than 45

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Sophie Bergeron

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophie Bergeron, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

274271

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CBCT-01

Identifier Type: -

Identifier Source: org_study_id