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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

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis

Eligibility Criteria

21 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

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

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

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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