Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
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
10 weekly individual 60-minute sessions
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Supportive Psychotherapy
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)
