Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia (CBCT-RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Sophie Bergeron, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01935063
First received: August 27, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Vulvodynia
Provoked Vestibulodynia
Vulvar Pain
Dyspareunia
Behavioral: Cognitive Behavioral Couple Therapy
Other: Topical Lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive-behavioral Couple Therapy and Lidocaine in the Treatment of Provoked Vestibulodynia: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Change in pain during intercourse / sexual activity from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Pain during intercourse will be assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever, as recommended by the IMMPACT guidelines for chronic pain clinical trials (Dworkin et al., 2005). Participants will report on pain experienced in the preceding month. The main outcome will be the change in the VAS scores from pre- to post-treatment. This measure has been shown to detect significant treatment effects in women with PVD (Bergeron et al., 2001) and demonstrates a significant positive correlation with other pain intensity measures. Pain during intercourse is the main symptom of PVD and the one that most interferes with quality of life, hence the most relevant measure of functional outcome.


Secondary Outcome Measures:
  • Change in qualitative components of pain from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Qualitative components of pain will also be assessed using the Short-Form McGill Pain Questionnaire (MPQ; Melzack, 1985), a measure of the sensory, affective and evaluative components of pain. The MPQ is a widely used adjective 15-item checklist which assesses both qualitative and quantitative aspects of pain (Grafton, Foster, & Wright, 2005; Melzack & Katz, 2001). We will use the Pain Rating Index (PRI) scale.

  • Changes in partner responses to pain from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Partner responses from the point of view of the women with PVD and their partners will be measured with the West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI; Kerns, Turk, & Rudy, 1985), and the Spouse Response Inventory - Facilitative subscale (SRI; Schwartz, Jensen, & Romano, 2005) which have been adapted to our PVD population and their partners.

  • Change in dyadic adjustment from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Dyadic adjustment will be assessed using the Couple Satisfaction Index (CSI; Funk & Rogge, 2007), a 32-item measure of relationship satisfaction. Compared to other well-known relationship satisfaction measures (e.g., Dyadic Adjustment Scale; Spanier, 1976) it demonstrates strong convergent validity, and a higher precision and power for detecting distinctions in satisfaction levels (Funk & Rogge, 2007). Moreover, unlike similar relationship satisfaction scales, the CSI has been tested with a sample of participants spanning the relationship spectrum (e.g., dating, engaged, married).

  • Change in pain catastrophizing for both women and partners from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS; Sullivan, Bishop, & Pivik, 1995), which consists of 13 items scored on a 5-point scale with the end points (0) not at all and (4) all the time. The PCS is divided into three subscales: rumination, magnification and helplessness. It is a reliable and valid measure that has demonstrated a stable factorial structure across clinical and general populations, including a French population (Sullivan, Bishop, & Pivik, 1995; Osman et al., 2000; French et al., 2005). Cano et al. (Cano, Leonard, & Franz, 2005) recently validated a partner version and found excellent psychometric properties.

  • Changes in pain attributions from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Pain attributions will be measured with the Extended Attributional Style Questionnaire (EASQ; Metalsky, Halberstadt, & Abramson, 1987), adapted for use with women who experience genital pain, and their partners. The adapted EASQ consists of 12 hypothetical negative situations that occur within a genital pain context, and participants are asked to indicate the major cause of the situation (open-ended), and then rate the cause on the following dimensions: internal, global, and stable on a 7-point Likert scale. The EASQ adapted for genital pain demonstrates good internal consistency (alpha=0.84-0.86) for subscales and total score, as well as a similar factor structure to the original EASQ (Jodoin et al., 2011). We have used both the woman and partner version successfully in previous studies (Jodoin et al., 2008; 2011).

  • Change in anxiety from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete the Trait Anxiety subscale of the Spielberger State-Trait Anxiety Inventory (STAI - (Spielberger, Gorsuch, & Lushene, 1970). This 20-item, well-known, and widely used measure has demonstrated very good psychometric properties in clinical and non-clinical populations, including in chronic pain (Gauthier & Bouchard, 1993; Greenberg & Burns, 2003; Rule & Traver, 1983; Tanaka-Masumi & Kameoka, 1986).

  • Change in depression symptoms to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete the Beck Depression Inventory-Fast Screen (BDI-FS; Beck, Steer, & Brown, 1996; Beck, Steer, & Garvin, 1988), an adapted 7-item version of the widely-used 21-item measure. Specifically, the BDI-FS assesses sadness, loss of pleasure (anhedonia), suicide ideation, pessimism, past failure, self-dislike and self criticalness with scores for items ranging from 0 (low intensity) to 3 (high intensity). This measure has been used with chronic pain populations (Poole, Bramwell, & Murphy, 2008).

  • Change in pain self-efficacy of women with PVD from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Pain self-efficacy will be assessed using the Painful Intercourse Self-Efficacy Scale (PISES; Desrochers et al., 2009), which was adapted from the Arthritis Self-Efficacy Scale (Lorig et al., 1989). The PISES consists of 20 items with three subscales: self-efficacy for controlling pain during intercourse, for sexual function, and for other symptoms. Participants indicate their perceived ability to carry out sexual activity or to achieve outcomes in pain management by responding on a scale from 10 (very uncertain) to 100 (very certain). Higher scores indicate greater self-efficacy. The reliability and validity of the original version have been established (Lorig et al., 1989) and the factor structure of the adapted version has been shown to be identical to that of the original (Desrochers, 2009). In our previous samples, Cronbach's alphas ranged from .79 to .89 for women and .74 to .91 for partners.

  • Self-reported improvement following treatment (duration of treatment is 12 weeks) [ Time Frame: Post-treatment, and 6-months post-treatment ] [ Designated as safety issue: No ]
    Woman and partner self-reported improvement [scale of 0 (worse) to 5 (complete cure)] and treatment satisfaction [scale of 0 (completely dissatisfied) to 10 (completely satisfied)] will be measured post-treatment and at 6-month follow-up to assess the clinical significance of results.

  • Change in sexual satisfaction for both partners from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Sexual satisfaction will be assessed using the Global Measure of Sexual Satisfaction scale, which consists of 5 items assessing global sexual satisfaction. Internal consistency of this scale is high (alpha = 0.90), as is test-retest reliability (r = 0.84; Lawrence & Byers, 1998).

  • Changes in sexual function from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Sexual function for both women and their partners will be assessed using the Derogatis Interview for Sexual Functioning - Self-Report (DISF-SR), a 25-item self-report measure of sexual function for men and women (Derogatis, 1997). It covers five dimensions of sexuality: sexual cognition/fantasy, arousal, sexual behaviour/experience, orgasm, and sexual drive/relationship. Scores can be calculated for each dimension and for global sexual functioning. The DISF-SR boasts good internal consistency and reliability (Derogatis, 1997; Meston & Derogatis, 2002; Daker-White, 2002).

  • Changes in quality of life from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete the Quality Metric™ Short Form 12-question Health Survey (SF-12). This reliable and valid survey was adapted from the widely-used SF-36 health survey and assesses physical and mental health and wellness across 8 scales: physical function, bodily pain, vitality, general health, emotional and physical roles, social functioning, and mental health (Cheak-Zamora, Wyrwich, & McBride, 2009; Ware, Kosinski, Keller, 1996). The SF-36 has been used previously in PVD samples (Sutton, Pukall, & Chamberlain, 2009).

  • Changes in attachment, or experiences in close relationships from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Attachment will be measured using the Experiences in Close Relationships Scale-Revised (ECR-RS; Wei, Russel, Mallinckrodt, & Vogel, 2007). The ECR-RS is a 12-item scale that assesses components of adult attachment (e.g., secure, anxious, avoidant attachment). Both members of the couple will complete this measure.

  • Change in interpersonal sexual goals from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Approach and avoidance interpersonal sexual goals will be assessed with a 15-item measure adapted from Cooper et al. (1998) (Impett, Peplau, & Gable, 2005; Impett et al., 2008; Impett, Gordon, & Strachman, 2008). Participants rate the importance of 9 approach and 6 avoidance interpersonal goals in influencing their decision to engage in sex on a 7-point scale. This measure has demonstrated high internal consistency (Impett et al., 2005; Impett et al., 2008).

  • Changes in communication patterns from baseline, and over the course of treatment [ Time Frame: Baseline, Weeks 1, 4, 8, and 12 of treatment ] [ Designated as safety issue: No ]
    At the pre-treatment, post-treatment, and follow-up evaluation sessions, both partners will complete the Communication Patterns Questionnaire - Short Form (Christensen & Heavey, 1990), an 11-item measure of communication patterns during couples' discussions of problems. This measure examines three overall patterns of communication: conflict avoiding, conflict engaging, and positive interaction (Futris et al., 2010). This measure has demonstrated good psychometric properties (Futris, Campbell, Nielsen, & Burwell, 2010). We will also collect 12 additional items from the full measure to assess the subscales of mutual avoidance, mutually constructive communication, and other communication patterns during and after periods of conflict (Christensen & Shenk, 1991).

  • Change in intimacy ratings from baseline, and over the course of treatment [ Time Frame: Baseline, Weeks 1, 4, 8, and 12 of treatment ] [ Designated as safety issue: No ]
    Both partners will complete measures of general relationship intimacy (8-items; Laurenceau et al., 2005) and sexual intimacy (12-items; Bois et al., 2013). These measures assess self-disclosure, partner disclosure, and partner responsiveness in the context of the interpersonal exchanges and sexual activity. They have demonstrated high internal consistency in our previous PVD research (Bois et al., 2013).

  • Changes in Fear of Pain from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Fear of pain will be measured using the Pain Anxiety Symptoms Scale (PASS-20; McCracken & Dhinga, 2002), a 20-item, self-report measure of fear of pain designed for individuals with chronic pain problems and has been adapted for use in a sexual context (i.e. the word sexual has been added before the word activity for several items). Subscales include: Cognitive Anxiety, Escape/Avoidance, Fearful appraisal, and Physiological Anxiety. Only women with PVD will complete this measure.

  • Changes in Hypervigilance to Pain from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Hypervigilance to pain during intercourse will be assessed with the Pain and Vigilance Awareness Questionnaire (PVAQ); McCracken, 1997), a 16-item measure of attention to pain that has been used to evaluate awareness, consciousness and vigilance to pain in various clinical and non-clinical populations. It shows good test-retest reliability and internal consistency (Roelofs et al., 2003). Only women with PVD will complete this measure.

  • Changes in Acceptance of Chronic Pain from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete an adapted version of the Chronic Pain Acceptance Questionnaire (McCracken, Vowles, &Eccleston, 2004) for use with women experiencing vulvovaginal pain and their partners. This 20-item scale measures acceptance and openness to experiencing pain sensations, and the pursuit of a satisfying life in spite of pain. The partner version references their own acceptance of their partner's pain. A recent systematic review of measures of acceptance of chronic pain indicated that, based on psychometric properties, there is the most support for use of the CPAQ to measure acceptance of pain in chronic pain patients, as compared to other questionnaires (Reneman et al., 2010). Studies using the CPAQ have found Cronbach's alpha of the sum score that ranges from 0.78-0.85.

  • Changes in female sexual function from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Only women with PVD will complete the Female Sexual Function Inventory (FSFI), a self-report 19-item measure assessing sexual functioning in women such as sexual arousal, orgasm, sexual satisfaction and discomfort experienced during sexual activity and intercourse with high internal consistency (i.e., high inter-item correlation for the six domains) and validity among several samples of women with sexual difficulties (Rosen et al., 2000; Meston, 2003; Wiegel, Meston & Rosen, 2005).

  • Changes in sexual distress from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete the Female Sexual Distress Scale, a 12-item measure designed to assess sexually related personal distress. Although designed for women, items are gender non-specific and could pertain to both women and men. Thus, no adaptations are required for use with male partners. This measure has demonstrated high internal consistency, test-retest reliability, discriminate validity, and construct validity (Derogatis et al., 2002).

  • Changes in Ambivalence over Emotional Expression from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Both partners will complete the Ambivalence over Emotional Expression Questionnaire (AEQ; King & Emmons, 1990). This measure assesses various aspects of ambivalence over expressing emotions (e.g., wanting to express but being unable to, expressing but not wanting to, or expressing and then regretting the decision). This self-report measure consists of 28 items. The AEQ has been shown to have good psychometric properties, including good internal stability, test-retest reliability and convergent validity (King & Emmons, 1990).

  • Changes in Dyadic Sexual Communication from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Dyadic sexual communication will be measured using the Dyadic Sexual Communication Scale (Catania, 1986). This measure is a 13-item scale that assesses partners' perceptions of their communication processes around sexual problems. Both members of the couple will complete this measure, which has demonstrated good reliability and a uni-factorial structure (Catania, Pollack, McDermott, Qualls, & Cole, 1990).

  • Changes in male sexual function from baseline to post-treatment, and 6-months post-treatment [ Time Frame: Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline) ] [ Designated as safety issue: No ]
    Male partners will complete the International Index of Erectile Function (IIEF; Rosen, Riley, Wagner, Osterloh, Kirkpatrick & Mishra, 1997). The IIEF is a well-known instrument for assessing erectile function in men. It is comprised of 15 items, and 3 items to assess pelvic pain in men have been added to this measure, and these items are complimentary to those that appear in the FSFI.


Other Outcome Measures:
  • History of trauma [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Trauma, a potential moderator of treatment response, will be assessed using the Childhood Trauma Questionnaire (CTQ), a 28-item self-report measure focusing on emotional, physical, and sexual abuse, as well as physical and emotional neglect in childhood (Berstein et al., 2003). The CTQ is the only self-report measure of childhood victimization with demonstrated criterion validity to detect actual abuse and neglect histories. Scores range from 5 to 25 for each type of abuse and a total severity scale can also be computed.

  • Therapeutic alliance over the course of treatment [ Time Frame: Treatment weeks 1, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Therapeutic alliance is defined by the expectations, agreements, and bond that forms between the therapist and the couple, as well between the therapist and each member of the couple (Pinsof & Caherall). We will measure this construct using the Revised Short Form Integrative Psychotherapy Alliance Scale for Couples, or the Couple Therapeutic Alliance Scale (CTASr-SF; Pinsof, Zinbarg, & Knobloch-Fedders, 2008) at four time points: at sessions 1, 4, 8, and 12. The CTASr-SF is a 12-item, self-report questionnaire. This scale is widely used in clinical work and research with couples, and alphas for all subscales is good (alpha = 0.70 or better). We have added a thirteenth item to assess ongoing satisfaction throughout the therapy process.

  • Treatment expectancies [ Time Frame: Measured following randomization but before treatment begins ] [ Designated as safety issue: No ]
    Using visual analog scales, we will ask participants to rate their expectancies related to their beliefs of efficacy pertaining to the treatment to which they were randomized. This measure has been successfully used in our previous clinical trial research.

  • History of relationship conflict [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Select questions from the Conflict Tactics Scale (CTS; Straus, Hamby, Boney-McCoy & Sugarman, 1996), and the NorVold Abuse Questionnaire (Swahnberg & Wijma, 2003) will be used to assess the presence of current (and past) physical and emotional abuse. These two measures were developed to assess the presence and history of relationship abuse (physical and emotional).


Estimated Enrollment: 224
Study Start Date: November 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Couple Therapy
CBCT is a 12-session therapy that includes the following: re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviours and couple interactions; psychoeducation about PVD and its impact upon sexuality, defining/working the sexual script, mindfulness techniques, communication skills training, and sexual approach/avoidance goals work, defusion and acceptance approaches to coping with pain, among others.
Behavioral: Cognitive Behavioral Couple Therapy
CBCT includes the following: (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 sexual functioning, reduce sexual distress and increase sexual satisfaction; (5) consolidate skills.
Other Name: CBCT
Active Comparator: Topical lidocaine
Nightly applications of a 5% lidocaine ointment on the vulvar vestibule, at the entry of the vagina (50mg/g, Xylocaïne®, AstraZeneca, tube of 35g) for 12 weeks, as described by Zolnoun et al. (Zolnoun, Hartmann, & Steege, 2003).
Other: Topical Lidocaine
Nightly applications of a 5% lidocaine ointment on the vulvar vestibule, at the entry of the vagina (50mg/g, Xylocaïne®, AstraZeneca, tube of 35g) for 12 weeks, as described by Zolnoun et al. (2003). In addition, the cream will be applied to a cotton ball kept on the vestibule via the participant's underwear overnight to ensure a continued 7 to 8-hour contact between the anesthetic and the vestibule. A pamphlet with figures detailing how to apply the cream will be given to participants, in addition to a calibrated measurement tool to ensure that all participants apply the same quantity every night.
Other Names:
  • Lidocaine
  • Xylocaine (R)
  • Nightly lidocaine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women with vulvar pain:

  • 1) pain during intercourse which a) is subjectively distressing, b) occurs on 80% of intercourse attempts, and c) has lasted for at least one year;
  • 2) pain limited to intercourse and other activities involving pressure to the vestibule;
  • 3) ability to undergo the gynecological examination to completion;
  • 4) significant pain in one or more locations of the vestibule during the gynecological exam, which is operationalized as a minimum average patient pain rating of 4 on a scale of 0 to 10;
  • 5) having engaged in vaginal intercourse as a couple once per month for the last three month;
  • 6) partnered in a committed, monogamous relationship for at least 6 months; and
  • 7) 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 for women with vulvar pain:

  • 1) vulvar pain not clearly linked to intercourse or pressure applied to the vestibule;
  • 2) 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;
  • 3) age less than 18 or greater than 45;
  • 4) current treatment for PVD.

Exclusion criteria for the partners are:

  • 1) major medical and/or psychiatric illness;
  • 2) age less than 18.

Exclusion criteria for couples include:

  • 1) severe relational distress or conflict as determined by baseline measures and interview;
  • 2) current participation in another couple therapy, or therapy/treatment related to PVD.

Both women and partners must be able to read, speak, and understand English or French (in Montreal), and English (in Halifax) to participate.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935063

Contacts
Contact: Mylène Desrosiers, MA 514-343-6111 ext 47688 mylene.desrosiers@umontreal.ca
Contact: Serena Corsini-Munt, MA, PhD Candidate 514-343-6111 ext 37428 serena.corsini-munt@umontreal.ca

Locations
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H 4R2
Contact: Kathy Petite, MA    902-494-4223    rosenlab@dal.ca   
Principal Investigator: Natalie O Rosen, PhD         
Canada, Quebec
University of Montreal Recruiting
Montreal, Quebec, Canada, H2V 2S9
Contact: Mylene Desrosiers, MSc    514-343-6111 ext 47688    mylene.desrosiers@umontreal.ca   
Contact: Serena Corsini-Munt, MA    514-343-6111 ext 37428    serena.corsini-munt@umontreal.ca   
Principal Investigator: Sophie Bergeron, PhD         
Sponsors and Collaborators
Université de Montréal
Investigators
Principal Investigator: Sophie Bergeron, PhD Université de Montréal
Principal Investigator: Natalie O Rosen, PhD Dalhousie University
  More Information

No publications provided

Responsible Party: Sophie Bergeron, Associate Professor, Psychology, Université de Montréal
ClinicalTrials.gov Identifier: NCT01935063     History of Changes
Other Study ID Numbers: CBCT-02, 299610
Study First Received: August 27, 2013
Last Updated: April 14, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Le comité d'éthique de la recherche sur les sujets humains (CÉR) de CHUM
Canada: IWK Health Centre - Research Ethics Board

Keywords provided by Université de Montréal:
Vulvodynia
Provoked vestibulodynia
Vulvar pain
Dyspareunia
Couples therapy
Lidocaine
Cognitive behavioral couple therapy
Cognitive behavioral therapy
Pain
Pain during sexual intercourse

Additional relevant MeSH terms:
Vulvodynia
Dyspareunia
Vulvar Diseases
Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014