A Randomized Clinical Trial for Women With Vulvodynia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-03-31

Brief Summary

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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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Detailed Description

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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

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Vulvodynia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive-behavioral Therapy

10 weekly individual 60-minute sessions

Group Type EXPERIMENTAL

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

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

Supportive Psychotherapy

10 weekly individual 60-minute sessions

Group Type ACTIVE_COMPARATOR

Supportive Psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive-Behavioral Therapy

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

Intervention Type BEHAVIORAL

Supportive Psychotherapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No