The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 16
- 主要终点
- Sexual functioning
研究概览
简要总结
Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and genital pain resulting in significant subjective distress. This study is aimed to assess a mindfulness-based intervention for improving sexual functioning among women with epilepsy
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older
- •Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more,
- •Currently in a relationship that has lasted longer than 1 year
- •Both members of the couple are able to speak and read Persian
- •Both members of the couple provide signed and dated informed consent form
排除标准
- •Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program
- •Major psychiatric disorder (e.g., psychosis, personality disorder)
- •Current suicidal ideation or suicide attempt within past 3 months
- •Past participation in an MBCT program
结局指标
主要结局
Sexual functioning
时间窗: changes from baseline, 1 Months and 6 months
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Intimacy
时间窗: changes from baseline, 1 Months and 6 months
Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales
sexuality-related distress
时间窗: changes from baseline, 1 Months and 6 months
The Female Sexual Distress Scale revised version (FSDS-R) is extensively validated and among the most widely used tools to measure sexually related personal distress.
次要结局
- Marital satisfaction(changes from baseline, 1 Months and 6 months)
- Psychological distress(changes from baseline, 1 Months and 6 months)
- Erectile Function(changes from baseline, 1 Months and 6 months)
- quality of life(changes of QOLIE-31-P from baseline, 1 Months and 6 months)
- Mindfulness for sexual functioning(changes from baseline, 1 Months and 6 months)
研究者
Amir H Pakpour
Director of Social Determinants of Health Research Center (SDH)
Qazvin University Of Medical Sciences