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

NCT01935063 | Completed

• 2 other identifiers: CBCT-02299610
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vulvodynia; Dyspareunia; Vestibulodynia

Keywords

Vulvodynia; Provoked vestibulodynia; Vulvar pain; Dyspareunia; Couples therapy; Lidocaine; Cognitive behavioral couple therapy; Cognitive behavioral therapy; Pain; Pain during sexual intercourse

Outcome Measures

Primary Outcomes (1)

• Change in pain during intercourse / sexual activity from baseline to post-treatment, and 6-months post-treatment

  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.

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

Secondary Outcomes (28)

• Change in qualitative components of pain from baseline to post-treatment, and 6-months post-treatment

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

• Changes in partner responses to pain from baseline to post-treatment, and 6-months post-treatment

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

• Change in dyadic adjustment from baseline to post-treatment, and 6-months post-treatment

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

• Change in pain catastrophizing for both women and partners from baseline to post-treatment, and 6-months post-treatment

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

• Changes in pain attributions from baseline to post-treatment, and 6-months post-treatment

  Baseline, Post-treatment (12 weeks), and 6-months post-treatment (9 months from baseline)

Other Outcomes (5)

• History of trauma

  Baseline

• Therapeutic alliance over the course of treatment

  Treatment weeks 1, 4, 8, and 12

• Treatment expectancies

  Measured following randomization but before treatment begins

Study Arms (2)

Cognitive Behavioral Couple Therapy

EXPERIMENTAL

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

Topical lidocaine

ACTIVE COMPARATOR

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

Interventions

Cognitive Behavioral Couple Therapy BEHAVIORAL

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.

Also known as: CBCT

Cognitive Behavioral Couple Therapy

Topical Lidocaine OTHER

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.

Also known as: Lidocaine, Xylocaine (R), Nightly lidocaine

Topical lidocaine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pain during intercourse which a) is subjectively distressing, b) occurs on 80% of intercourse attempts, and c) has lasted for at least six months;
• 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.

You may not qualify if:

• 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) dermatologic lesion, d) 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (2)

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

University of Montreal

Montreal, Quebec, H2V 2S9, Canada

Location

Related Publications (2)

• Santerre-Baillargeon M, Rosen NO, Vaillancourt-Morel MP, Corsini-Munt S, Steben M, Mayrand MH, Bergeron S. Mediators of change in cognitive-behavioral couple therapy for genito-pelvic pain: Results of a randomized clinical trial. Health Psychol. 2023 Mar;42(3):161-171. doi: 10.1037/hea0001274.

  PMID: 36862472 DERIVED

• Corsini-Munt S, Bergeron S, Rosen NO, Steben M, Mayrand MH, Delisle I, McDuff P, Aerts L, Santerre-Baillargeon M. A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: study protocol for a randomized clinical trial. Trials. 2014 Dec 23;15:506. doi: 10.1186/1745-6215-15-506.

  PMID: 25540035 DERIVED

MeSH Terms

Conditions

Vulvodynia; Dyspareunia; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sophie Bergeron, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Natalie O Rosen, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychology

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 4, 2013
• Study Start: March 6, 2014
• Primary Completion: March 19, 2018
• Study Completion: December 10, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)