A Cognitive Behavioral Group Program-plus for Women With Dyspareunia: A Randomized Waiting List Controlled Multi-center Trial of Efficacy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Mean level of pain during penile/vaginal intercourse (PI)
研究概览
简要总结
The current study will employ a group CBT treatment program of 10 group sessions and 3 individual couple sessions targeting the thoughts, emotions, behaviors and couple interactions associated with the experience of dyspareunia. Women with superficial dyspareunia and their partners will be randomized to the CBT group program-plus or a waiting list control period at one treatment location in Sweden and two treatment locations in the Netherlands. The waiting-list control period will be comparable to the treatment duration of six months.
It is hypothesized that the group program-plus is more effective in improving pain during intercourse in women with superficial dyspareunia compared to women on a waiting-list control period.
详细描述
Rationale:
Superficial dyspareunia, a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. While recent research has showed that cognitive-behavioral therapy (CBT) interventions have effects in regards to reducing pain, enhancing sexual function and improving relational aspects, randomized controlled trials are still sparse. Despite recommendations in the literature to include the partner in the CBT treatment targeted at improving pain and sexuality outcomes, there are no published randomized CBT controlled trials incorporating the partner in the treatment.
Primary objective: To evaluate whether the group program-plus improves pain during intercourse in women with superficial dyspareunia compared to women in a waiting-list control condition.
Secondary Objective(s): are to evaluate a) women (and partners) sexuality (sexual function, distress & satisfaction), b) women's psychological adjustment (negative and positive penetration beliefs, pain/penetration coping behavior); c) relationship factors (partner responses and relationship satisfaction), and whether an improvement in pain during intercourse is moderated by pre-treatment patient characteristics, such as age, sexual functioning, relationship satisfaction, abuse history, and mediated by a) reduction of negative penetration beliefs, avoidance behavior and/or improvement in positive penetration beliefs and sexual function (i.e. sexual arousal).
Study design:
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years old
- •in a heterosexual relationship for at least 3 months
- •diagnosis of superficial dyspareunia (in accordance to DSM5) with no apparent ongoing physical cause to the condition (i.e. ongoing infections).
- •past experience of a successful intercourse
- •attempted intercourse during the last year
排除标准
- •reporting to never have had full intercourse at any time in life
- •partner not willing to participate in the study
- •major affective disorder, psychotic disorder, substance-related disorder or post traumatic-stress disorder related to the genitals (e.g., as a sequel to sexual abuse) according to DSM-5 criteria
- •being pregnant
- •gone through child delivery during the last year
- •not speaking Dutch or Swedish well enough to participate in assessment and treatment
- •receiving concurrent psychological therapy or physiotherapy for superficial dyspareunia during CBT or WLC period.
结局指标
主要结局
Mean level of pain during penile/vaginal intercourse (PI)
时间窗: 6 months; 9 months; 12 months
Pain intensity is measured on a scale between 0-10
次要结局
- Female Sexual Distress scale (FSDS)(6 months; 9 months; 12 months)
- Painful Intercourse Self-Efficacy Scale (PISES)(6 months; 9 months; 12 months)
- Genital pain rating questionnaire (GPQ)(6 months; 9 months; 12 months)
- Penetration behavior questionnaire (PBQ)(6 months; 9 months; 12 months)
- Global Measure of Sexual Satisfaction Scale (GMSEX)(6 months; 9 months; 12 months)
- CHAMP Sexual Pain Coping Scale (CSPCS)(6 months; 9 months; 12 months)
- Approach and Avoidance Sexual Goals (AASG)(6 months; 9 months; 12 months)
- Female Sexual Function Index (FSFI)(6 months; 9 months; 12 months)
- Maudsley Marital Questionnaire (MMQ)(6 months; 9 months; 12 months)
- Vaginal Penetration Cognition Questionnaire (VPCQ)(6 months; 9 months; 12 months)