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A Randomized Clinical Trial for Women With Vulvodynia

Primary Purpose

Vulvodynia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Supportive Psychotherapy
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis

Eligibility Criteria

21 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Independently diagnosed with vulvodynia by two study physicians

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive-behavioral Therapy

    Supportive Psychotherapy

    Arm Description

    10 weekly individual 60-minute sessions

    10 weekly individual 60-minute sessions

    Outcomes

    Primary Outcome Measures

    Pain Severity

    Secondary Outcome Measures

    Sexual Functioning
    Emotional Functioning

    Full Information

    First Posted
    January 22, 2008
    Last Updated
    May 20, 2016
    Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00607490
    Brief Title
    A Randomized Clinical Trial for Women With Vulvodynia
    Official Title
    Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.
    Detailed Description
    Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vulvodynia
    Keywords
    Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-behavioral Therapy
    Arm Type
    Experimental
    Arm Description
    10 weekly individual 60-minute sessions
    Arm Title
    Supportive Psychotherapy
    Arm Type
    Active Comparator
    Arm Description
    10 weekly individual 60-minute sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive-Behavioral Therapy
    Intervention Description
    Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Supportive Psychotherapy
    Intervention Description
    Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
    Primary Outcome Measure Information:
    Title
    Pain Severity
    Time Frame
    Measured at 1-year follow-up
    Secondary Outcome Measure Information:
    Title
    Sexual Functioning
    Time Frame
    Measured at 1-year follow-up
    Title
    Emotional Functioning
    Time Frame
    Measured at 1-year follow-up

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Independently diagnosed with vulvodynia by two study physicians Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robin M Masheb, Ph.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Randomized Clinical Trial for Women With Vulvodynia

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