An interventional study of Cognitive-Behavioral Therapy and Supportive Psychotherapy in Vulvodynia, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed. Open to female participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Treatment
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.
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.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 50 is above the median of 44 across 79 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 weekly individual 60-minute sessions
Behavioral: Cognitive-Behavioral Therapy
10 weekly individual 60-minute sessions
Behavioral: Supportive Psychotherapy
Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
Pain Severity
Time frame: Measured at 1-year follow-up
Sexual Functioning
Time frame: Measured at 1-year follow-up
Emotional Functioning
Time frame: Measured at 1-year follow-up
No study locations are listed for this record.
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)