An Avatar-based Intervention in Second Life for Female Orgasmic Disorder: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire
研究概览
简要总结
A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Intervention was based on the cognitive behavioral therapy approach (treatment with the most empirical evidence) and previous literature about FOD. It consisted of 12 weekly online individual sessions and aimed at improving the FOD diagnosis, sexual variables, and variables that are known to affect orgasm consecution. Control group was based on minimum therapeutic contact. Changes over time in the assessed variables were analyzed using linear mixed models, considering treatment group, measurement time point, and group-by-time interactions as fixed effects. Effect sizes were computed (Cohen's d; number needed to treat - NNT; reliable change index - RCI).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Present the characteristics to diagnose female orgasm disorder after a clinic assessment (considering natural characteristics of the women's sexual response cycle (Conn & Hodges, 2022) based on the DSM-5 criteria.
- •Provide a medical check to prove the absence of physical factors that may be the cause of the orgasm dysfunction, as this is the first part to diagnose FOD.
- •Be at least 18 years old (adult).
- •Have access to a computer with the characteristics to run Second Life and internet connection.
排除标准
- •Present a diagnosis of a physical condition that may be the cause of the orgasm dysfunction (e.g., genital lesions, systemic and hormonal factors, vulvovaginal atrophy).
- •Presence of other psychological pathology (e.g., depression, trauma) that may be the cause of the orgasm dysfunction.
- •Have alcohol dependence (i.e., evaluated during the clinical assessment, according to the diagnostic criteria from the DSM-5, to determine if the individual meets the criteria for an alcohol use disorder diagnosis).
- •Drug use, including medication that is known to cause sexual difficulties (e.g., selective serotonin reuptake inhibitors (SSRIs), that are a particularly common drug cause of sexual dysfunction.
- •Have participated in a previous psychological intervention in the last year.
结局指标
主要结局
Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire
时间窗: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Initiative and Sexual Communication is the proactive and consensual expression of one's sexual desires, interests, and intentions within the context of a sexual relationship or encounter. The Female Sexual Function Questionnaire has minimum-maximum values of 14-70; higher scores mean a better outcome. The cut-off for determining significantly low levels of this variable are scores equal to or lower than 25.
Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction
时间窗: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual satisfaction is the feeling of pleasure that one has when the sexual desire has been fulfilled. The Golombok Rust Inventory of Sexual Satisfaction has minimum-maximum values of 0-112; higher scores mean a worse outcome. The cut-off for determining significant levels of Sexual Satisfaction is 60 (scores equal to or above 60 indicate the existence of a sexual problem).
Sexual functionassessed by the Female Sexual Function Index
时间窗: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual function refers to the capacity of having a satisfactory sexual life. The Female Sexual Function Index has minimum-maximum values of 19-95; higher scores mean a better outcome. The cut-off for determining significant levels of this variable is 55 (scores equal to or below 55 indicate poor Sexual Function).
次要结局
- Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale(From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up)
- Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale(From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up)
- Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory(From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up)
研究者
Ariana Vila
Principal investigator
Universidad Rey Juan Carlos