NCT06607042尚未招募不适用
BEDIT-RCT: Randomized Controlled Study on the Effectiveness of Berlin Dissexuality Therapy as Part of the Model Project in Accordance With §65d German Social Security Code V
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Abstinence
研究概览
简要总结
The main goal of this clinical trial is to learn if psychotherapy works to reduce consumption of child abuse imagages.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at first presentation minimum 18 years
- •Voluntary consent to participation on the part of the participant
- •At the time of inclusion, no contact with the justice system (ongoing investigation, ongoing criminal proceedings, ongoing prison sentence) due to sexually abusive behavior towards children
- •Sexually conspicuous behavior and/or fantasies or impulses that indicate the presence of a pedophilic and/or hebephilic preference disorder.
- •An offer of treatment is made when a suspected diagnosis is confirmed or the diagnosis is confirmed
- •Feared or recent use of abusive images
- •Sufficient knowledge of German
- •Voluntary participation in the study and checking the checkbox in the informed consent form before starting participation
排除标准
- •Age under 18 years
- •Lack of consent on the part of the patient
- •Exclusion of the presence of a pedophilic and/or hebephilic preference disorder
- •Current legal status in the sense of an ongoing investigation or criminal proceedings due to sexually assaultive behavior towards children
- •Severe comorbidities: unstable psychotic disorder, organic brain damage, reduced intellectual capacity (IQ below 70), untreated drug or alcohol addiction or persistent harmful use
- •Current risk of child sexual abuse and or child sexual abuse that occurred less than 15 years before the start of the study
- •An antiandrogenic medication or an opiate antagonist, during therapy start taking a serotonin reuptake inhibitor.
结局指标
主要结局
Abstinence
时间窗: From enrollment to the end of treatment 12 - 18 weeks
Abstinence rates for the consumption of abusive images
次要结局
- Frequency of abstinence rates(From enrollment to the end of treatment 12 - 18 weeks)
- Sexual preoccupation(From enrollment to the end of treatment 12 - 18 weeks)
- Cognitive distortions about child sexual abuse(From enrollment to the end of treatment 12 - 18 weeks)
- Emotion regulation(From enrollment to the end of treatment 12 - 18 weeks)
- Mental Health(From enrollment to the end of treatment 12 - 18 weeks)
- General well-being(From enrollment to the end of treatment 12 - 18 weeks)
研究者
Klaus Michael Beier
Director, Institute for Sexual Research and Sexual Medicine
Charite University, Berlin, Germany
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