Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01704456
Study type	Interventional
Source	University of British Columbia
Contact
Status	Completed
Phase	N/A
Start date	October 2012
Completion date	September 2017

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See also
Status	Clinical Trial	Phase
Completed	`NCT02543593` - Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial	N/A
Completed	`NCT01996384` - Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study	Phase 1
Completed	`NCT01731288` - Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain	N/A
Completed	`NCT04545255` - The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)	N/A
Terminated	`NCT01149031` - Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia	N/A
Completed	`NCT01753258` - Outcomes of Delivery in Patients With Dyspareunia	N/A
Completed	`NCT04045041` - Internet-based Treatment for Provoked Vestibulodynia	N/A
Recruiting	`NCT05797480` - Dry Needling for Provoked Vestibulodynia	N/A
Recruiting	`NCT05909514` - Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia	N/A
Completed	`NCT04234542` - Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With Provoked Vestibulodynia?	N/A
Completed	`NCT04208204` - Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study	N/A
Completed	`NCT01704443` - Integrated Mindfulness for Provoked Vestibulodynia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms