A Randomized Clinical Trial for Women With Vulvodynia

Study Description

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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	Phase
Vulvodynia	Behavioral: Cognitive-Behavioral Therapy; Behavioral: Supportive Psychotherapy	Not Applicable

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

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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
Actual Primary Completion Date :	March 2005
Actual Study Completion Date :	March 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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