Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia
Information source: Université de Montréal
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvodynia; Dyspareunia; Vestibulodynia
Intervention: Cognitive Behavioral Couple Therapy (Behavioral); Topical Lidocaine (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Université de Montréal Official(s) and/or principal investigator(s): Sophie Bergeron, PhD, Principal Investigator, Affiliation: UniversitĂ© de MontrĂ©al Natalie O Rosen, PhD, Principal Investigator, Affiliation: Dalhousie University
Overall contact: Mylène Desrosiers, MA, Phone: 514-343-6111, Ext: 47688, Email: mylene.desrosiers@umontreal.ca
Summary
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? 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, couple satisfaction, attachment, and communication
styles), and self-reported improvement and treatment satisfaction. 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.
Clinical Details
Official title: A Comparison of Cognitive-behavioral Couple Therapy and Lidocaine in the Treatment of Provoked Vestibulodynia: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in pain during intercourse / sexual activity from baseline to post-treatment, and 6-months post-treatment
Secondary outcome: Change in qualitative components of pain from baseline to post-treatment, and 6-months post-treatmentChanges in partner responses to pain from baseline to post-treatment, and 6-months post-treatment Change in dyadic adjustment from baseline to post-treatment, and 6-months post-treatment Change in pain catastrophizing for both women and partners from baseline to post-treatment, and 6-months post-treatment Changes in pain attributions from baseline to post-treatment, and 6-months post-treatment Change in anxiety from baseline to post-treatment, and 6-months post-treatment Change in depression symptoms to post-treatment, and 6-months post-treatment Change in pain self-efficacy of women with PVD from baseline to post-treatment, and 6-months post-treatment Self-reported improvement following treatment (duration of treatment is 12 weeks) Change in sexual satisfaction for both partners from baseline to post-treatment, and 6-months post-treatment Changes in sexual function from baseline to post-treatment, and 6-months post-treatment Changes in quality of life from baseline to post-treatment, and 6-months post-treatment Changes in attachment, or experiences in close relationships from baseline to post-treatment, and 6-months post-treatment Change in interpersonal sexual goals from baseline to post-treatment, and 6-months post-treatment Changes in communication patterns from baseline, and over the course of treatment Change in intimacy ratings from baseline, and over the course of treatment Changes in Fear of Pain from baseline to post-treatment, and 6-months post-treatment Changes in Hypervigilance to Pain from baseline to post-treatment, and 6-months post-treatment Changes in Acceptance of Chronic Pain from baseline to post-treatment, and 6-months post-treatment Changes in female sexual function from baseline to post-treatment, and 6-months post-treatment Changes in sexual distress from baseline to post-treatment, and 6-months post-treatment Changes in Ambivalence over Emotional Expression from baseline to post-treatment, and 6-months post-treatment Changes in Dyadic Sexual Communication from baseline to post-treatment, and 6-months post-treatment Changes in male sexual function from baseline to post-treatment, and 6-months post-treatment Changes in self-compassion from baseline to post-treatment, and 6-months post-treatment
Detailed description:
Background: Chronic pain problems involving the female reproductive system are major health
concerns in women of all ages. As conditions which are poorly understood and often
misdiagnosed or ignored, 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. A recent population-based study suggests that the lifetime cumulative incidence of
vulvodynia is 16%, indicating that approximately 2. 5 million Canadian women may experience
idiopathic vulvar pain during their lifetimes. Provoked vestibulodynia (PVD) - an acute
recurrent pain localized within the vulvar vestibule and experienced primarily during sexual
intercourse - is suspected to be the most frequent cause of vulvodynia in premenopausal
women, with prevalence estimates of 12% in community samples. Despite its high prevalence
and negative impact on psychosexual functioning, there has been a paucity of controlled
research to provide empirically validated treatments for afflicted couples. The present
proposal draws on our previous cross-sectional and prospective CIHR funded research on the
dyadic determinants of pain and psychosexual impairment in women with PVD and their
partners, as well as on our past randomized trials evaluating the efficacy of group
cognitive-behavioral therapy for this condition. Specifically, the goal of our study is to
evaluate the efficacy of a targeted cognitive-behavioral couple therapy (CBCT) intervention
that we developed for the treatment of PVD.
Objectives: The proposed two-centre randomized clinical trial aims to evaluate the efficacy
of a novel 12-week targeted couple therapy intervention (CBCT) for women with PVD in
comparison to one of the most frequently prescribed first line medical interventions,
topical lidocaine, shown to be effective and safe in the management of PVD. The primary
research question focuses on whether there is a significant difference between the two
treatments on women's pain during intercourse post-treatment. Secondary research questions
focus on whether there are significant differences between the two treatments post-treatment
and at 6-month follow-up on (a) the multidimensional aspects of women's pain on the McGill
Pain Questionnaire and (b) women and partners' sexuality (sexual function and satisfaction,
frequency of intercourse), psychological adjustment (anxiety, depression, catastrophizing,
self-efficacy, pain attributions, and quality of life), relationship factors (partner
responses, dyadic adjustment, attachment, and communication) and self-reported improvement
and treatment satisfaction. We will also examine whether childhood trauma and co-morbid pain
conditions moderate treatment response.
Research plan/methodology: The proposed research is a 3. 5-year, two-centre parallel
randomized controlled trial for PVD using an intent-to-treat analysis strategy, with pain
during intercourse as the primary outcome. The main research questions will be addressed by:
1) recruiting 224 premenopausal women and their partners with medically diagnosed PVD; 2)
performing comprehensive gynecological and psychosexual pre-treatment evaluations focusing
on our outcome measures; 3) randomly assigning women to one of the two 12-week treatment
arms: CBCT or lidocaine, and 4) evaluating pain during intercourse, as well as sexual,
psychological and relationship outcomes, in addition to self-reported improvement and
treatment satisfaction, post-treatment and at 6-month follow-up. These procedures will take
place in two different university centers: Université de Montréal in Montréal, Québec, and
Dalhousie University in Halifax, Nova Scotia, and their affiliated hospitals. Both
university centres will store data securely, adhering to the protocols outlined by the
ethics review boards at each site.
Statistical Analyses Analyses: will be conducted based on intention to treat. Descriptive
statistics will be used to define and compare the participants in both intervention groups.
More specifically, we will calculate means, medians, deviations and interquartile ranges and
T-tests will be used to determine the differences between groups for socio-demographic
variables. Chi-square tests and observed differences between groups will be used for
categorical variables. If differences are observed between groups, these variables will be
controlled for in subsequent analyses. We will verify that variables are normally
distributed. If variables are not normally distributed, non-parametric tests will be
employed. A repeated measures analysis of variance will permit the assessment of efficacy of
the two treatments at post-treatment and at 6-month follow-up. The analyses will focus on
the changes in pain experienced during intercourse from pre-treatment assessment to
post-treatment and 6-months follow-up. To do this, time will be the intra-subject variable,
and the experimental condition will be the inter-subject variable.
For secondary analysis, multiple analyses will be conducted in multiple steps, with
multivariate analyses being conducted first for repeated measures (MANOVA). Correlated
measures will be grouped based on conceptual domain (e. g., pain, dyadic adjustment,
catastrophizing). Univariate analyses will be conducted if the multivariate results are
significant (ANOVA). This will be followed by orthogonal contrasts to examine changes
between different measurements. Moreover, we will use exploratory analyses for participants
who completed the experimental protocol to determine the effect protocol adherence has on
treatment efficacy. Multiple regression analyses will be used to examine the link between
socio-demographic variables, pre-treatment dependent variables and pain at post-treatment
and 6-months follow-up to identify factors associated with therapeutic success. These latter
analyses will be conducted for each treatment group separately. Bonferroni corrections will
be used during analyses for multiple comparison adjustments. In the case of missing data, we
will explore the effects of withdrawal on sensitivity analyses, replace the missing data
with data from the most recent assessment or with averaged or aggregate values.
Significance of study: Results of the proposed research may improve the health and quality
of life of Canadians afflicted with a highly prevalent and neglected women's health problem
- vulvodynia - by providing a rigorous test of the efficacy of a novel targeted couple
therapy intervention.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- pain during intercourse which a) is 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;
- ability to undergo the gynecological examination to completion;
- significant pain in one or more locations of the vestibule during the gynecological
exam, which is operationalized as a minimum patient pain rating of 4 on a scale of 0
to 10;
- having engaged in vaginal intercourse as a couple once per month for the last three
month;
- partnered in a committed, monogamous relationship for at least 6 months; and
- has had at least four in-person contacts per week with their partner for at least six
months.
- Partners will be recruited conditional upon the patient meeting study selection
criteria.
- Both women and partners must be able to read, speak, and understand English or French
(in Montreal), and English (in Halifax) to participate.
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) dermatologic lesion, f) pregnancy or
planning a pregnancy;
- age less than 18 for couples or greater than 45 for women with pain;
- major medical and/or psychiatric illness for partners;
- severe relational distress or conflict as determined by baseline measures and
interview;
- current participation in another couple therapy, or therapy/treatment related to PVD.
Locations and Contacts
Mylène Desrosiers, MA, Phone: 514-343-6111, Ext: 47688, Email: mylene.desrosiers@umontreal.ca
Dalhousie University, Halifax, Nova Scotia B3H 4R2, Canada; Recruiting Kathy Petite, MA, Phone: 902-494-4223, Email: rosenlab@dal.ca Natalie O Rosen, PhD, Principal Investigator
University of Montreal, Montreal, Quebec H2V 2S9, Canada; Recruiting Mylene Desrosiers, MA, Phone: 514-343-6111, Ext: 47688, Email: mylene.desrosiers@umontreal.ca Serena Corsini-Munt, MA, Phone: 514-343-6111, Ext: 37428, Email: serena.corsini-munt@umontreal.ca Sophie Bergeron, PhD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: May 7, 2015
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