A Randomized Clinical Trial for Women With Vulvodynia

Study Overview
=================
Brief 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.

Official Title
-----------------
Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

Conditions
-----------------
Vulvodynia

Intervention / Treatment
-----------------
* Behavioral: Cognitive-Behavioral Therapy
* Behavioral: Supportive Psychotherapy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral Therapy<br>10 weekly individual 60-minute sessions | Behavioral: Cognitive-Behavioral Therapy<br>* Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.<br>|
| Active Comparator: Supportive Psychotherapy<br>10 weekly individual 60-minute sessions | Behavioral: Supportive Psychotherapy<br>* Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity |  | Measured at 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Functioning |  | Measured at 1-year follow-up | 
| Emotional Functioning |  | Measured at 1-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis