Take Your Sexuality Back - a Feasibility Study of a New Intervention for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sexual satisfaction
研究概览
简要总结
This study looks at the potential effects of a new group treatment called "Take Your Sexuality Back", designed for women who have experienced sexual trauma. Investigators will collect information in two ways-through forms that participants fill out themselves and through ECG measurements during a stress tests. Data will be collected before the treatment, right after it, and again three months later. When all data are collected and analyzed investigators will carry out in-depth interviews with participants and explore how they felt about being tested and how they understand the results -especially if some numbers look unusual or surprising. The goal with this study is to create a strong foundation for a future larger-scale study of the treatment by testing the methods, estimating the size of possible effects and identify outcome measurements that are experienced as meaningful to the participants.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A history of sexual trauma.
- •Experience trauma-related sexual problems.
- •Age between 18 and 65 years.
- •Enough competence in Norwegian to participate in a psychoeducational group.
排除标准
- •Acute suicidality.
- •Serious substance abuse interfering with treatment
- •Severe dissociative or psychotic disorders.
- •Current life crisis interfering with treatment.
- •Living in an abusive relationship. -
结局指标
主要结局
Sexual satisfaction
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention)
The Sexual Satisfaction Scale for women (SSS-W). Different Likert scales. Higher scores mean worse outcome. Higher scores mean better outcome.
Sexual shame
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Sexual shame index-revised (SSI-R). One (1) is equivalent to strongly disagree and 6 indicates strongly agree. Higher scores mean worse outcome.
Interoceptive awareness
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Multidimensional Assessment of Interoceptive Awareness (MAYA 2). Zero is equivalent with never and 5 indicates always. Higher scores mean better outcome.
Responses to script-driven imagery.
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Responses to script-driven imagery (RSDI) measures emotional, cognitive, and physiological responses in the script-driven imagery procedure. Zero is equivalent to "not at all" and six (6) indicates "very much". Higher scores mean worse outcome.
Touch body map
时间窗: From enrollment to 3 months after end of the treatment (12 weeks intervention).
Touch Body Map is an instrument for mapping how the body reacts to touch. Participants color the outlines of a human figure with three colors to mark how different areas of the body react to touch form a loved one. The body map gives a non-verbal expression of how trauma is embodied. The percentage of the different colors will be calculated to assess possible changes through the process
Change in HRV and SampEn from pre-post and at follow up efter 3 month.
时间窗: Enrollment to 3 months after end of treatment (12 weeks intervention).
Cardiovascular measurement (ECG) recorded during a script-driven imagery (SDI). HRV and SampEn.
Participants experiences of being tested and their understanding of the results.
时间窗: Three month after end of treatment, when all quantitative results are analyzed and calculated.
In-depth interviews with focus on participants own experiences and understanding og the quantitative results.
PTSD-symptoms and complex PTSD symptoms
时间窗: From enrollment to 3 month after end of treatment (12 weeks treatment)
The international trauma questionnaire (ITQ). Zero (0) is equivalent to nothing and 4 indicates extremely. Higher scores mean worse outcome.
Sexual satisfaction
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention)
The Sexual Satisfaction Scale for women (SSS-W). Different Likert scales. Higher scores mean worse outcome. Higher scores mean better outcome.
Sexual shame
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Sexual shame index-revised (SSI-R). One (1) is equivalent to strongly disagree and 6 indicates strongly agree. Higher scores mean worse outcome.
Interoceptive awareness
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Multidimensional Assessment of Interoceptive Awareness (MAYA 2). Zero is equivalent with never and 5 indicates always. Higher scores mean better outcome.
Responses to script-driven imagery.
时间窗: From enrollment to 3 months after end of treatment (12 weeks intervention).
The Responses to script-driven imagery (RSDI) measures emotional, cognitive, and physiological responses in the script-driven imagery procedure. Zero is equivalent to "not at all" and six (6) indicates "very much". Higher scores mean worse outcome.
Touch body map
时间窗: From enrollment to 3 months after end of the treatment (12 weeks intervention).
Touch Body Map is an instrument for mapping how the body reacts to touch. Participants color the outlines of a human figure with three colors to mark how different areas of the body react to touch form a loved one. The body map gives a non-verbal expression of how trauma is embodied. The percentage of the different colors will be calculated to assess possible changes through the process
Change in HRV and SampEn from pre-post and at follow up efter 3 month.
时间窗: Enrollment to 3 months after end of treatment (12 weeks intervention).
Cardiovascular measurement (ECG) recorded during a script-driven imagery (SDI). HRV and SampEn.
Participants experiences of being tested and their understanding of the results.
时间窗: Three month after end of treatment, when all quantitative results are analyzed and calculated.
In-depth interviews with focus on participants own experiences and understanding og the quantitative results.
次要结局
未报告次要终点