SHER 2: Internet-delivered Emotion Regulation Skills Training for Sexual Health: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in Female Sexual Function Index (FSFI) at 6 months
研究概览
简要总结
Introduction: Emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2 study are: a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction, and; b) explore the effects of the intervention on (1) emotion regulation skills; (2) mental health; (3) sexual self-perception.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 18 and 65 years of age,
- •fluent in Brazilian Portuguese,
- •self-reported sexual problems, assessed in men by a score of < 21 on the International Index Erectile Function (IIEF) and in women by a score of < 26 on the Female Sexual Function Index (FSFI),
- •in a stable relationship for at least the preceding 3 months.
排除标准
- •medical conditions that can interfere with the outcomes of the intervention, e.g., diabetes, cancer, cardiovascular problems,
- •ongoing psychotherapy.
- •no sexual activity in the previous 4 weeks.
结局指标
主要结局
Change in Female Sexual Function Index (FSFI) at 6 months
时间窗: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
this is a 19-item questionnaire for the assessment of sexual functioning in women in domains of sexual functioning (e.g., sexual arousal, orgasm, satisfaction, pain). Answers are provided using a 5-point Likert scale.
Change in International Index of Erectile Function (IIEF)at 6 months
时间窗: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
The IIEF is 15-item, self-administered questionnaire for assessing sexual functioning in men. Answers are given on a 6-point Likert scale. The IIEF encompasses five different domains of sexual functioning: erectile function, orgasm function, sexual desire, intercourse satisfaction and overall satisfaction.
Change in Sexual Quotient (QS) at 6 months
时间窗: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
The QS is a brief and comprehensive tool composed of 10-questions, which are answered on a scale from 0 (never) to 5 (always). It addresses general sexual function, and stages of the sexual response cycle (desire, arousal, orgasm) and sexual satisfaction.
次要结局
- Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale(baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up))
- Sexual Self-Schema Scale (SSSS).(baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up))
- Patient Health Questionnaire-9 (PHQ-9)(baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up))
- General Anxiety Disorder - 7 (GAD-7)(baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up))
- the Difficulties in Emotion Regulation Scale (DERS)(baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up))