A Randomized Clinical Trial for Women With Vulvodynia
Primary Purpose
Vulvodynia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Supportive Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia focused on measuring Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-behavioral Therapy
Supportive Psychotherapy
Arm Description
10 weekly individual 60-minute sessions
10 weekly individual 60-minute sessions
Outcomes
Primary Outcome Measures
Pain Severity
Secondary Outcome Measures
Sexual Functioning
Emotional Functioning
Full Information
NCT ID
NCT00607490
First Posted
January 22, 2008
Last Updated
May 20, 2016
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00607490
Brief Title
A Randomized Clinical Trial for Women With Vulvodynia
Official Title
Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia
Keywords
Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral Therapy
Arm Type
Experimental
Arm Description
10 weekly individual 60-minute sessions
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
10 weekly individual 60-minute sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
Primary Outcome Measure Information:
Title
Pain Severity
Time Frame
Measured at 1-year follow-up
Secondary Outcome Measure Information:
Title
Sexual Functioning
Time Frame
Measured at 1-year follow-up
Title
Emotional Functioning
Time Frame
Measured at 1-year follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin M Masheb, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Randomized Clinical Trial for Women With Vulvodynia
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