Clinical trial NCT01582373: Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia
Official title: Pilot Study to Assess the Efficacy of an Experimental 12-week Cognitive-behavioral Couple Therapy in the Treatment of Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibulodynia
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain during intercourse (Visual analog scale)
timeFrame: change in the VAS scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Secondary outcomes:
measure: Sexual function (Derogatis Interview for Sexual Functioning - Self-Report)
timeFrame: change in the DISF-SR scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Global Measure of Sexual Satisfaction scale
timeFrame: change in GMSEX scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
measure: West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI)
timeFrame: changes in MPI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Couple Satisfaction Index (CSI)
timeFrame: changes in CSI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: changes in PSC scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: changes in STAI from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Self-reported improvement and satisfaction
timeFrame: Reported at the end of treatment
measure: Painful Intercourse Self-Efficacy Scale (PISES)
timeFrame: Changes in PISES scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
measure: Beck Depression Inventory (BDI-II)
timeFrame: changes in BDI-II scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Sophie Bergeron, PhD
role: PRINCIPAL_INVESTIGATOR
References: