A Randomized Clinical Trial for Women With Vulvodynia

Vulvodynia Clinical Trial

Official title:

Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607490
• Other study ID #: R01HD038493
• Status: Completed
• Phase: N/A
• First received: January 22, 2008
• Last updated: May 20, 2016
• Start date: September 2000
• Est. completion date: March 2005

Study information

• Verified date: January 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvodynia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity		Measured at 1-year follow-up	No
Secondary	Sexual Functioning		Measured at 1-year follow-up	No
Secondary	Emotional Functioning		Measured at 1-year follow-up	No