Trial record 9 of 13 for:    Open Studies | "Vulvodynia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01704456
First received: August 22, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 more efficacious than an 8-session CBT intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.


Condition Intervention
Provoked Vestibulodynia
Behavioral: Mindfulness-based Cognitive Therapy
Behavioral: Cognitive Behavioural Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in pain intensity from baseline to one month post-treatment [ Time Frame: one week pre-treatment to one month post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Sexual distress [ Time Frame: Pre-treatment,one month post-treatment, and 6- and 12-months follow-up. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women).


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

PURPOSE:

The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is more efficacious 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).
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704456

Contacts
Contact: Kelly B Smith, PhD 604-875-8258 Kelly.Smith@vch.ca
Contact: Lori A Brotto, PhD 604-875-4111 ext 68898 lori.brotto@vch.ca

Locations
Canada, British Columbia
British Columbia Centre for Sexual Medicine Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Kelly B Smith, PhD    604-875-8258    kelly.smith@vch.ca   
Contact: Lori A Brotto, PhD    604-875-4111 ext 68898    lori.brotto@vch.ca   
Principal Investigator: Lori A Brotto, PhD         
Department of Gynaecology Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Kelly B Smith, PhD    604-875-4111 ext 68901    kelly.smith@vch.ca   
Contact: Lori A Brotto, PhD    604-875-4111 ext 68898    lori.brotto@vch.ca   
Principal Investigator: Lori A Brotto, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Lori A Brotto, PhD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01704456     History of Changes
Other Study ID Numbers: H12-02358
Study First Received: August 22, 2012
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
provoked vestibulodynia
dyspareunia
vulvodynia
mindfulness
cognitive behavioural therapy

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014