NCT00607490

Brief Summary

This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
Last Updated

May 23, 2016

Status Verified

January 1, 2008

Enrollment Period

4.5 years

First QC Date

January 22, 2008

Last Update Submit

May 20, 2016

Conditions

Vulvodynia

Keywords

VulvodyniaVulvar painDyspareuniaSexual dysfunctionVestibulitis

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Measured at 1-year follow-up

Secondary Outcomes (2)

  • Sexual Functioning

    Measured at 1-year follow-up

  • Emotional Functioning

    Measured at 1-year follow-up

Study Arms (2)

Cognitive-behavioral Therapy

EXPERIMENTAL

10 weekly individual 60-minute sessions

Behavioral: Cognitive-Behavioral Therapy

Supportive Psychotherapy

ACTIVE COMPARATOR

10 weekly individual 60-minute sessions

Behavioral: Supportive Psychotherapy

Interventions

Cognitive-Behavioral TherapyBEHAVIORAL

Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.

Cognitive-behavioral Therapy
Supportive PsychotherapyBEHAVIORAL

Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.

Supportive Psychotherapy

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Independently diagnosed with vulvodynia by two study physicians

You may not qualify if:

  • Any conditions known to better account for the vulvar pain
  • Psychotic illness
  • Actively suicidal
  • Substance dependent
  • Life-threatening illness
  • Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

VulvodyniaDyspareuniaSexual Dysfunction, Physiological

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robin M Masheb, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

September 1, 2000

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

May 23, 2016

Record last verified: 2008-01