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

NCT01582373 | Completed

• 2 other identifiers: CBCT-01274271
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibulodynia

Outcome Measures

Primary Outcomes (1)

• Pain during intercourse (Visual analog scale)

  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. The main outcome will be the change in the VAS scores from pre- to post-treatment. This method for measuring pain has been shown to detect significant treatment effects in women with PVD 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.

  change in the VAS scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment

Secondary Outcomes (9)

• Sexual function (Derogatis Interview for Sexual Functioning - Self-Report)

  change in the DISF-SR scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment

• Global Measure of Sexual Satisfaction scale

  change in GMSEX scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment

• West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI)

  changes in MPI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment

• Couple Satisfaction Index (CSI)

  changes in CSI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment

• Pain Catastrophizing Scale (PCS)

  changes in PSC scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment

Study Arms (1)

Cognitive-behavioral couple therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-behavioral couple therapy

Interventions

Cognitive-behavioral couple therapy 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).

Also known as: Cognitive Behavioral Pain and Sex Therapy (CBPST)

Cognitive-behavioral couple therapy

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 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

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) 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

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sophie Bergeron, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CA (1)