A Randomized Clinical Trial for Women With Vulvodynia

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00607490
First received: January 22, 2008
Last updated: February 4, 2008
Last verified: January 2008
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual Functioning [ Time Frame: Measured at 1-year follow-up ] [ Designated as safety issue: No ]
  • Emotional Functioning [ Time Frame: Measured at 1-year follow-up ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2000
Study Completion Date: March 2005
Estimated 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

Ages Eligible for Study:   21 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607490

Sponsors and Collaborators
Investigators
Principal Investigator: Robin M Masheb, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Robin Masheb, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00607490     History of Changes
Other Study ID Numbers: R01HD38493
Study First Received: January 22, 2008
Last Updated: February 4, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 22, 2014