Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Female Sexual Distress Scale-Revised (FSDS-R)
研究概览
简要总结
The purpose of this study is to determine whether an 8-session mindfulness-based intervention (MBCT group) is effective for women with low sexual interest/desire in reducing sexual distress, improving their sexual response, and increasing their mindful skills, compared to a support group.
详细描述
HYPOTHESES:
- Compared to baseline, the MBCT group will have significant post-treatment improvements in self-report measures of: (a) sexual distress; (b) sexual desire, subjective sexual arousal, perception of genital arousal, and sexual pleasure; (c) relationship satisfaction; (d) depressive symptoms and rumination; (e) perceived stress, general anxiety, anxiety sensitivity, and sexuality-related situational anxiety (as self-reported at the sexual arousal assessment); and (f) mindfulness, self-compassion, non-attachment, and interoceptive awareness.
- Compared to baseline, the MBCT group will have significant post-treatment improvements in laboratory physiological measures of: (a) genital sexual response as measured by a vaginal photoplethysmograph, (b) interoceptive awareness, as measured by a heart rate perception task, and (c) cortisol:DHEA ratio as measured by hormonal assays of saliva samples.
- We hypothesize that the changes in the endpoints listed in #1 or #2 will be significantly greater in the MBCT group than in the support group.
- We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal.
- Mindfulness, self-compassion, and interoceptive awareness will significantly mediate improvements in sexual distress and desire in the MBCT group at all post-treatment assessment points.
- Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group.
- Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points.
- We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must be experiencing distressing sexual interest/desire and/or sexual arousal concerns
- •must between the ages of 19 - 65
- •must be fluent in English
排除标准
- •not experiencing distressing sexual interest/desire and/or sexual arousal concerns
- •not between the ages of 19-65
- •unable to read, write, speak and understand English
结局指标
主要结局
Female Sexual Distress Scale-Revised (FSDS-R)
时间窗: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.
Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
Sexual Interest and Desire Inventory (SIDI)
时间窗: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.
The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) will be used to measure sexual desire. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
Rumination
时间窗: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.
Rumination was measured with the Rumination-Reflection Questionnaire - Adapted Rumination Subscale (adapted from Trapnell \& Campbell, 1999 to inquire about sexuality-related rumination). Likert scale 1 - 5 with higher score indicating higher rumination.
Relationship Assessment Scale (RAS)
时间窗: 2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.
Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988). Scoring: Add each item score and divide by 7 to get a mean score. Higher score relates to higher satisfaction. Minimum mean score 1, maximum score 5.
次要结局
- Subjective Sexual Arousal(Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I)
- Interoceptive Awareness(Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I)
- Physiological Sexual Arousal(Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I)
- Stress Hormone Cortisol Slope(Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I)
研究者
Lori Brotto
Professor, UBC Department of Gynaecology
University of British Columbia