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A Randomized Clinical Trial for Women With Vulvodynia

This study has been completed.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: January 22, 2008
Last updated: May 20, 2016
Last verified: January 2008
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

Condition Intervention
Behavioral: Cognitive-Behavioral Therapy
Behavioral: Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

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

Enrollment: 50
Study Start Date: September 2000
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT00607490     History of Changes
Other Study ID Numbers: R01HD038493 ( US NIH Grant/Contract Award Number )
Study First Received: January 22, 2008
Last Updated: May 20, 2016

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 processed this record on May 25, 2017