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Completed

NCT Number: NCT00607490

A Randomized Clinical Trial for Women With Vulvodynia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.

supportive psychotherapy

Behavioral

Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.

Primary outcomes

  1. Pain Severity

    Time frame: Measured at 1-year follow-up

Secondary outcomes

  1. Sexual Functioning

    Time frame: Measured at 1-year follow-up

  2. Emotional Functioning

    Time frame: Measured at 1-year follow-up

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Registry information

Official study title

Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Feb 5, 2008
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.