Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Change in sexual distress
研究概览
简要总结
Female sexual dysfunction (FSD) affects approximately one-third of women worldwide and is linked to negative physical, psychological, and interpersonal outcomes. Although both cognitive-behavioral therapy and mindfulness-based therapy are effective treatments for FSD, face-to-face treatments can be costly and are inaccessible to many people in remote areas. The goal of the current study is to pilot a randomized controlled trial to examine the effectiveness of and satisfaction with two online interventions for FSD. Women will be randomized to an online cognitive-behavioral program, an online mindfulness-based program, or a wait-list control group. Treatment will be administered entirely online and last 8-12 weeks. Women will meet weekly via Zoom with a navigator who will provide individualized support.
详细描述
HYPOTHESES:
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the primary outcomes: (a) sexual distress and (b) sexual desire.
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the secondary outcomes: (a) overall sexual function, (b) sexual satisfaction, (c) relational sexual concern, (d) satisfaction with life, and (e) relationship satisfaction.
- Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points.
- Higher levels of baseline relationship satisfaction, higher levels of partner involvement, more positive baseline expectations about treatment efficacy, higher levels of treatment compliance, and perceiving higher levels of empathy and effectiveness from navigators will predict greater improvements in primary outcomes at post-treatment and follow-up.
- Baseline personality will moderate intervention effects at post-treatment and follow-up.
- Women in both the CBT and MBT arms will report being satisfied with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cis and trans women of any sexual orientation.
- •Must be fluent in English (online materials delivered in English).
- •Must have consistent access to the internet, basic competency in using online platforms (self-report).
- •Must be in a committed, stable romantic relationship of at least 6 months (because aspects of the interventions require partner participation). Partners may be of any gender.
- •Must meet telephone screening diagnostic criteria for sexual interest/arousal disorder.
- •Must be sexually active with a partner over the preceding 4 weeks (due to the sexual function outcome measure), and willing to engage in sexual activity with their partner during the study.
- •Must be able to participate in an 8-12-week online treatment.
排除标准
- •Have sexual dysfunction that is, in their estimation, fully attributable to another psychiatric diagnosis, the effect of a substance, a general medical condition (e.g., Multiple Sclerosis), or non-sexual conflict in the relationship, none of which are meant to be addressed by the proposed interventions.
- •Poorly managed Anxiety or Mood Disorder (as per degree of life interference assessed at screening).
- •Report visual impairments that would make it difficult to read online materials.
- •Are regularly using prescription narcotics illegal recreational drug (not including cannabis).
- •Plan to change their medications known to impact sexual function over the course of the study.
- •On assessment report plans to end their romantic relationship in the next 6 months.
- •Engage in any other treatment for their sexual difficulties during the study.
结局指标
主要结局
Change in sexual distress
时间窗: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0-52, where higher scores represent higher levels of distress.
Change in sexual desire
时间窗: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) total score will be used to measure sexual desire. Possible total scores range from 0-51, with higher scores indicating higher levels of sexual functioning.
次要结局
- Change in relationship satisfaction(baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up)
- Change in relational sexual concern(baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up)
- Treatment satisfaction for module 2(An average of 2 weeks after starting the 8-module program)
- Treatment satisfaction for module 3(An average of 3 weeks after starting the 8-module program)
- Treatment satisfaction for module 4(An average of 5 weeks after starting the 8-module program)
- Treatment satisfaction for module 6(An average of 7 weeks after starting the 8-module program)
- Change in sexual satisfaction(baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up)
- Treatment satisfaction for module 7(An average of 9 weeks after starting the 8-module program)
- Treatment satisfaction for module 8(An average of 10 weeks after starting the 8-module program)
- Treatment satisfaction for module 1(An average of 1 week after starting the 8-module program)
- Treatment satisfaction for module 5(An average of 6 weeks after starting the 8-module program)
- Change in sexual function(baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up)
- Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction(post-treatment (within 2 weeks of completing the 8-module program))
- Qualitative program treatment satisfaction(through completion of the 8-module program, an average of 10 weeks)
- Change in satisfaction with life(baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up)
研究者
Lori Brotto
Principal Investigator
University of British Columbia