Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia

NCT ID: NCT01704456

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-09-30

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.

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).

Conditions

Provoked Vestibulodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-based Cognitive Therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBCT; CBT

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Lori Brotto

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori A Brotto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, Canada

Department of Gynaecology

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32843320 (View on PubMed)

Related Links

http://brottolab.med.ubc.ca

UBC Sexual Health Lab

https://med-fom-brotto.sites.olt.ubc.ca/files/2019/07/Brotto-et-al.-A-comparison-of-mindfulness2019.pdf

Published Paper

Other Identifiers

H12-02358

Identifier Type: -

Identifier Source: org_study_id