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NCT02919813 · ClinicalTrials.gov registry record · NA

M-gCBT for Women With Provoked Localized Vulvodynia

A NA study of Provoked Localized Vulvodynia, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
31
Enrollment target
1
Study location

NCT02919813: Completed NA study of Provoked Localized Vulvodynia, sponsored by Oregon Health and Science University.

NCT02919813 is a NA study of Provoked Localized Vulvodynia that has completed, run by Oregon Health and Science University. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02919813, a NA study of Provoked Localized Vulvodynia, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions, including chronic pain conditions. The investigators wish to see if participation in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than education alone. Both techniques use a group setting including other women with PLV. "Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia" is a study designed to learn more about the use of mindfulness based group cognitive behavior therapy for PLV pain and anxiety over education alone. Participants will be randomized to one of two groups: mindfulness based cognitive behavior therapy or group education seminars.

Primary Outcome

The change from baseline in pain measured by the Tampon Test at 6 months. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.

Interventions

  • BEHAVIORAL Mindfulness Based Group Cognitive BehaviorTherapy
  • BEHAVIORAL Educational Seminars

Study Locations (1)

Oregon

  • Oregon Health and Science University - Portland

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2015-12-16
Est. Completion 2017-09-30
Phase NA

What the finished NCT02919813 record still lists

NCT02919813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Provoked Localized Vulvodynia appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness Based Group Cognitive BehaviorTherapy is the first listed.

NCT02919813 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT02919813 about?

NCT02919813 is a clinical study titled "M-gCBT for Women With Provoked Localized Vulvodynia". The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions, including chronic pain c...

What is the current status of trial NCT02919813?

This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2015-12-16. Estimated completion is 2017-09-30.

What conditions does trial NCT02919813 study?

This clinical trial studies the following conditions: Provoked Localized Vulvodynia.

What interventions are being tested in trial NCT02919813?

The interventions under investigation include: Mindfulness Based Group Cognitive BehaviorTherapy (BEHAVIORAL), Educational Seminars (BEHAVIORAL).

Who is sponsoring clinical trial NCT02919813?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02919813 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02919813's enrollment target sits among peer trials

31 1592nd of 2000 higher than 408 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02919813, the US trial registry maintained by the National Library of Medicine. NCT02919813 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.