NCT00607490

A Randomized Clinical Trial for Women With Vulvodynia

Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

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.

Conditions

• Vulvodynia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Therapy	Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
BEHAVIORAL	Supportive Psychotherapy	Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.

Timeline

• Start date: 2000-09-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2008-02-05
• Last updated: 2016-05-23