Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Female Sexual Desire Questionnaire (FSDQ)
研究概览
简要总结
Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. The broad aim of the proposed study is to validate this new protocol in a clinic that provides empirically-supported assessment and intervention services for women with menopause-related symptoms. The primary objective of this study is to evaluate the efficacy of a four-week individual CBT protocol in improving sexual satisfaction and reducing distress during perimenopause. The secondary objective of this study is to evaluate the efficacy of this CBT protocol to improve sexual functioning (e.g., desire, arousal), relationship satisfaction, and body image. Exploratory analyses will examine the impact on this CBT protocol on vasomotor symptoms, depression, and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40-60 years of age;
- •peri-menopausal and have had a menstrual period within the previous twelve months as per the STRAW definition (Harlow et al., 2012);
- •cut-off score of 26 or lower on the Female Sexual Functioning Index, indicating sexual dysfunction (Wiegel et al., 2005);
- •medication stable (e.g., hormone therapy), with no changes in dosing for the previous three months (Green et al., 2019);
- •no psychological treatment to address sexual dysfunction and/or sexual concerns within the previous six months; and
- •speak, read, and write in English to comprehend testing procedures and written materials in treatment
- •living within Canada
排除标准
- •participants with psychotic disorders, or current substance and/or alcohol dependence; and
- •participants who are severely depressed/suicidal at time of the intake assessment.
结局指标
主要结局
Female Sexual Desire Questionnaire (FSDQ)
时间窗: 6 weeks
The FSDQ (Goldhammer \& McCabe, 2011) is a 50-item self-report questionnaire assessing one's experience of and sexual desire for women across six domains: dyadic desire, solitary desire, resistance, positive relationship, sexual self-image, and concern. Total scores range from 50 to 300, with higher scores indicated increased sexual desire.
The Female Sexual Function Index (FSFI)
时间窗: 6 weeks
The FSFI (Rosen et al., 2000) is a six domain measure of female sexual functioning including sexual desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Scores on the FSFI range from 2-36, which higher scores indicating a greater level of sexual function.
Female Sexual Distress Scale-Revised (FSDS-R)
时间窗: 6 weeks
The FSDS-R (DeRogatis et al., 2008) is a 13-item self-report questionnaire assessing various aspects of sexual distress, with a clinical cut-off score of 11 indicated sexual distress. Scores on the FSDS-R range from 0 to 48, with higher scores indicating greater sexual distress.
次要结局
- 36-Item Short-Form Health Survey (SF-36)(6 weeks)
- The Beck Depression Inventory-II (BDI-II)(6 weeks)
- The Couples Satisfaction Index (CSI)(6 weeks)
- The Hot Flash Related Daily Interference Scale (HFRDIS)(6 weeks)
- The Greene Climacteric Scale (GCS)(6 weeks)
- The Hamilton Anxiety Scale (HAM-A)(6 weeks)
- Cognitive Flexibility Inventory (CFI)(6 weeks)
- Dresden Body Image Questionnaire (DBIQ)(6 weeks)
研究者
Sheryl Green
Clinical Psychologist, Principal Investigator
St. Joseph's Healthcare Hamilton