Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
COMFORT
1 other identifier
interventional
130
1 country
2
Brief Summary
This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart. The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2020
February 1, 2020
3.9 years
August 22, 2012
October 9, 2019
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment
The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).
Pre-treatment, one month post-treatment and 6 months post-treatment.
Secondary Outcomes (7)
Self-reported Pain During Penetration
Pre-treatment,one month post-treatment, and 6 months follow-up.
Sexual Function
Pre-treatment, one month post-treatment, and 6 months post-treatment.
Sexual Distress
Pre-treatment, one month post-treatment, and 6 months post-treatment.
Pain Catastrophizing
Pre-treatment, one month post-treatment, and 6 months post-treatment..
Pain Hypervigilance
Pre-treatment, one month post-treatment, and 6 months post treatment.
- +2 more secondary outcomes
Study Arms (2)
Mindfulness-based cognitive therapy (MBCT)
EXPERIMENTALWomen in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
Cognitive Behavioural Therapy (CBT)
EXPERIMENTALWomen in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
Interventions
The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
Eligibility Criteria
You may qualify if:
- diagnosis of provoked vestibulodynia (PVD)
- years of age or older
- premenopausal
- fluent in English
- during the study, women must agree not to change any medications they are taking for PVD.
You may not qualify if:
- unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
- being uncomfortable and unwilling to participate in a group setting.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
British Columbia Centre for Sexual Medicine
Vancouver, British Columbia, V5Z 1M9, Canada
Department of Gynaecology
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (1)
Brotto LA, Zdaniuk B, Rietchel L, Basson R, Bergeron S. Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia. J Sex Med. 2020 Nov;17(11):2247-2259. doi: 10.1016/j.jsxm.2020.07.080. Epub 2020 Aug 22.
PMID: 32843320DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Lori Brotto
- Organization
- UBC
Study Officials
- PRINCIPAL INVESTIGATOR
Lori A Brotto, PhD
University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 22, 2012
First Posted
October 11, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-02