Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia (COMFORT)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Provoked Vestibulodynia	Behavioral: Mindfulness-based Cognitive Therapy; Behavioral: Cognitive Behavioural Therapy	Not Applicable

Detailed Description:

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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.	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
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.	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

Outcome Measures

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Primary Outcome Measures :

1. 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).
2. 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).

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. 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).
5. 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).

Eligibility Criteria

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Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, British Columbia
British Columbia Centre for Sexual Medicine
Vancouver, British Columbia, Canada, V5Z 1M9
Department of Gynaecology
Vancouver, British Columbia, Canada, V5Z 1M9

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Lori A Brotto, PhD	University of British Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

UBC Sexual Health Lab 

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
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