Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse

Pedophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663047
• Other study ID #: Prevent It 2.0/GPP
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Karolinska Institutet
• Contact: Christoffer Rahm, MD
• Phone: +46-8-123 700 00
• Email: Christoffer.rahm[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• concern about sexual urges regarding children

• Informed consent to participate

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pedophilia

Intervention

Other:
• Prevent It 2.0
A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention
• Waitlist
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.

Locations

Country	Name	City	State
Sweden	CPF - centrum för psykiatriforskning.	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Johns Hopkins Bloomberg School of Public Health, The Royal Ottawa Mental Health Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Is Prevent It 2 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire (NEQ-20)?	NEQ-20 taps the occurrence (binary, yes or no) and severity (on a 5-point Likert scale 0-4, ranging from not at all to extremely) of 20 statements regarding negative effects of psychological treatment and ends with one free-text question. For each statement answered with yes , the respondent also reports whether they believe the negative effect is caused by "the treatment I received" or "other circumstances". Maximum score = 80, Minimum score = 0.	Up to 13 weeks
Other	Comparisons of attrition rates in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Other	Comparisons of SChiMRA in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Other	Comparisons of NEQ-20 in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?		Up to 13 weeks
Primary	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	Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.	Up to 13 weeks
Secondary	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?	The Sexual Child Molestation Risk Assessment, there's no scoring system at the moment. It's all item-by-item. But for all items, higher values are worse (e.g., more hours watching CSAM, more motivation to interact with children, etc).	Up to 13 weeks