N/A
N=130
Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
Provoked Vestibulodynia
Bottom Line
View on ClinicalTrials.gov: NCT01704456 ↗Enrolled (actual)
130
Serious AEs
—
Results posted
Mar 2020
Primary outcome: Primary: Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment — 6.66; 6.62; 3.21; 3.60 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-based Cognitive Therapy (Behavioral); Cognitive Behavioural Therapy (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment |
6.66; 6.62; 3.21; 3.60; 2.92; 2.86 | — |
| SECONDARY Self-reported Pain During Penetration |
6.69; 5.86; 4.34; 4.65; 3.39; 4.03 | — |
| SECONDARY Sexual Function |
19.57; 21.18; 21.79; 23.41; 24.75; 23.20 | — |
| SECONDARY Sexual Distress |
34.28; 35.68; 26.60; 24.93; 22.81; 23.77 | — |
| SECONDARY Pain Catastrophizing |
26.92; 25.62; 15.64; 12.57; 11.55; 10.83 | — |
| SECONDARY Pain Hypervigilance |
43.24; 42.46; 39.74; 40.32; 38.50; 38.76 | — |
| SECONDARY Chronic Pain Acceptance, Activities Engagement |
42.40; 42.39; 47.97; 46.63; 49.24; 47.83 | — |
| SECONDARY Chronic Pain Acceptance, CPAQ Pain Willingness |
23.99; 22.91; 29.34; 29.20; 33.72; 31.29 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01704456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.