跳至主要内容
临床试验/NCT05663047
NCT05663047已完成不适用

Prevent It 2.0/GPP - Internet Mediated Cognitive Behavioral Therapy to Reduce the Risk of Committing Child Sexual Abuse - Global Perpetrator Prevention Project

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2022年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
2
主要终点
1. Is Prevent It 2.0 effective in reducing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale)?involving children

研究概览

简要总结

Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing.

Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects.

Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children.

The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior.

Recruitment will be carried out through multiple channels, and takes place on both "Darknet" and "Clearnet". All contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi, designed specifically for clinical trials of Internet-mediated CBT.

The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.

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

入选标准

  • concern about sexual urges regarding children
  • Informed consent to participate

排除标准

  • Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse)
  • Participants that are judged to have a limited understanding of the languages that the treatment is delivered in (English)
  • Lack serious intention to participate (assessed by the researcher/therapist during the intake interview, which lasts approximately one hour)

结局指标

主要结局

1. Is Prevent It 2.0 effective in reducing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale)?involving children

时间窗: Up to 13 weeks

Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.

次要结局

  • Is Prevent It 2.0 effective in reducing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B?(Up to 13 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Rahm

MD, Principal Investigator

Karolinska Institutet

研究点 (2)

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