Clinical trial NCT01704456: Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
Official title: Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Vestibulodynia
Keywords: provoked vestibulodynia
dyspareunia
vulvodynia
mindfulness
cognitive behavioural therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 130
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment
timeFrame: Pre-treatment, one month post-treatment and 6 months post-treatment.
Secondary outcomes:
measure: Self-reported Pain During Penetration
timeFrame: Pre-treatment,one month post-treatment, and 6 months follow-up.
measure: Sexual Function
timeFrame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
measure: Sexual Distress
timeFrame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
measure: Pain Catastrophizing
timeFrame: Pre-treatment, one month post-treatment, and 6 months post-treatment..
measure: Pain Hypervigilance
timeFrame: Pre-treatment, one month post-treatment, and 6 months post treatment.
measure: Chronic Pain Acceptance, Activities Engagement
timeFrame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
measure: Chronic Pain Acceptance, CPAQ Pain Willingness
timeFrame: Pre-treatment, one month post-treatment, and 6 months post treatment.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Centre for Sexual Medicine
state: British Columbia
city: Vancouver
country: Canada
facility: Department of Gynaecology
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.