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A Randomized Clinical Trial for Women With Vulvodynia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607490
First Posted: February 5, 2008
Last Update Posted: May 23, 2016
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.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
  Eligibility

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
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.
  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)
Investigators
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 Submitted: January 22, 2008
First Posted: February 5, 2008
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):
Vulvodynia
Vulvar pain
Dyspareunia
Sexual dysfunction
Vestibulitis

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female