Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia (COMFORT)
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ClinicalTrials.gov Identifier: NCT01704456 |
Recruitment Status
:
Completed
First Posted
: October 11, 2012
Last Update Posted
: February 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Provoked Vestibulodynia | Behavioral: Mindfulness-based Cognitive Therapy Behavioral: Cognitive Behavioural Therapy | Not Applicable |
PURPOSE:
The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for improving women's pain intensity and reducing their sexual distress, catastrophizing and hypervigilance towards pain. The investigators will also examine whether pain improvements at follow-up are mediated by changes in self-compassion and mindfulness (in the MBCT arm only) and moderated by pre-treatment credibility, personality, and anxiety sensitivity.
HYPOTHESES:
- At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in vestibular pain intensity compared to women in the CBT arm.
- At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in sex-related distress, pain catastrophizing, hypervigilance, and self-reported pain during intercourse/other penetrative sex compared to women in the CBT arm.
- The investigators hypothesize that improvements in pain intensity during vestibular touch will be mediated by changes in self-compassion and mindfulness in the MBCT arm only at 6 and 12 months follow-up.
- The investigators hypothesize that pre-treatment credibility, personality, and anxiety sensitivity will significantly moderate improvements in pain intensity during vestibular touch at 6 and 12 months follow-up.
- The investigators hypothesize improvements in both arms on the "Patient Global Impression of Change Scale" and significantly greater improvements in the MBCT arm relative to the CBT arm at follow-up (4 weeks, 6 months and 12 months post-treatment).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | September 2017 |
Arm | Intervention/treatment |
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Experimental: Mindfulness-based cognitive therapy (MBCT)
Women 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.
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Behavioral: Mindfulness-based Cognitive Therapy
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.
Other Name: MBCT
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Experimental: Cognitive Behavioural Therapy (CBT)
Women 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.
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Behavioral: Cognitive Behavioural Therapy
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.
Other Name: CBT
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- Change in pain intensity from baseline to one month post-treatment [ Time Frame: one week pre-treatment to one month 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 (Pukall et al., 2004, 2007). 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).
- Change in pain intensity from baseline to 6 months post-treatment [ Time Frame: One week pre-treatment to 6 months post-preatment ]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 (Pukall et al., 2004, 2007). 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).
- Change in pain intensity from baseline to 12 months post-treatment [ Time Frame: one week pre-treatment to 12 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 (Pukall et al., 2004, 2007). 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).
- Sexual distress [ Time Frame: Pre-treatment,one month post-treatment, and 6- and 12-months follow-up. ]The investigators will examine women's self-reported sexual distress by administering the the Female Sexual Distress Scale-Revised (Derogatis, Clayton, Lewis-D'Agostino, Wunderlich, & Fu, 2008).
- Pain Catastrophizing [ Time Frame: Pre-treatment,one month post-treatment, and 6- and 12-months follow-up. ]The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
- Pain hypervigilance [ Time Frame: Pre-treatment,one month post-treatment, and 6- and 12-months follow-up. ]The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire (McCracken, 1997).
- Self-reported pain during penetration [ Time Frame: Pre-treatment,one month post-treatment, and 6- and 12-months follow-up. ]The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women).

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosis of provoked vestibulodynia (PVD)
- 19 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.
Exclusion Criteria:
- unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
- being uncomfortable and unwilling to participate in a group setting.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704456
Canada, British Columbia | |
British Columbia Centre for Sexual Medicine | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Department of Gynaecology | |
Vancouver, British Columbia, Canada, V5Z 1M9 |
Principal Investigator: | Lori A Brotto, PhD | University of British Columbia |
Additional Information:
Responsible Party: | Lori Brotto, Associate Professor, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01704456 History of Changes |
Other Study ID Numbers: |
H12-02358 |
First Posted: | October 11, 2012 Key Record Dates |
Last Update Posted: | February 21, 2018 |
Last Verified: | February 2018 |
Keywords provided by Lori Brotto, University of British Columbia:
provoked vestibulodynia dyspareunia vulvodynia mindfulness cognitive behavioural therapy |
Additional relevant MeSH terms:
Vulvodynia Vulvar Vestibulitis Vulvar Diseases Genital Diseases, Female Vulvitis |