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临床试验/NCT00607490
NCT00607490已完成不适用

Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)0 个研究点目标入组 50 人开始时间: 2000年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
主要终点
Pain Severity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Independently diagnosed with vulvodynia by two study physicians

排除标准

  • •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.

研究组 & 干预措施

Cognitive-behavioral Therapy

Experimental

10 weekly individual 60-minute sessions

干预措施: Cognitive-Behavioral Therapy (Behavioral)

Supportive Psychotherapy

Active Comparator

10 weekly individual 60-minute sessions

干预措施: Supportive Psychotherapy (Behavioral)

结局指标

主要结局

Pain Severity

时间窗: Measured at 1-year follow-up

次要结局

  • Sexual Functioning(Measured at 1-year follow-up)
  • Emotional Functioning(Measured at 1-year follow-up)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

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