Clinical trial NCT05663047: Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pedophilia
Keywords: Child sexual abuse
Pedophilic disorder
Preventive psychiatry
Internet based intervention
Cognitive behavioral therapy
Waitlist
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Royal Ottawa Mental Health Centre
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2022-12-23
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: 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?
timeFrame: Up to 13 weeks
Other outcomes:
measure: Is Prevent It 2 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire (NEQ-20)?
timeFrame: Up to 13 weeks
measure: Comparisons of attrition rates in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?
timeFrame: Up to 13 weeks
measure: Comparisons of SChiMRA in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?
timeFrame: Up to 13 weeks
measure: Comparisons of NEQ-20 in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1?
timeFrame: Up to 13 weeks
Locations:
city: Stockholm
country: Sweden
facility: CPF - centrum för psykiatriforskning.
Study officials:
affiliation: Karolinska Institutet
name: Christoffer Rahm, MD
role: PRINCIPAL_INVESTIGATOR
References: