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A Randomized Clinical Trial for Women With Vulvodynia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00607490
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : May 23, 2016
Information provided by:

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.

Condition or disease Intervention/treatment
Vulvodynia Behavioral: Cognitive-Behavioral Therapy Behavioral: Supportive Psychotherapy

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
Study Start Date : September 2000
Primary Completion Date : March 2005
Study Completion Date : March 2005
Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive-behavioral Therapy
10 weekly individual 60-minute sessions
Behavioral: Cognitive-Behavioral Therapy
Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
Active Comparator: Supportive Psychotherapy
10 weekly individual 60-minute sessions
Behavioral: Supportive Psychotherapy
Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.

Outcome Measures

Primary Outcome Measures :
  1. Pain Severity [ Time Frame: Measured at 1-year follow-up ]

Secondary Outcome Measures :
  1. Sexual Functioning [ Time Frame: Measured at 1-year follow-up ]
  2. Emotional Functioning [ Time Frame: Measured at 1-year follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607490

Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Robin M Masheb, Ph.D. Yale University
More Information

Responsible Party: Robin Masheb, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00607490     History of Changes
Other Study ID Numbers: R01HD038493 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: January 2008

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Vulvar pain
Sexual dysfunction

Additional relevant MeSH terms:
Vulvar Diseases
Genital Diseases, Female