PedophiliaNCT05663047
Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse
A study testing Prevent It 2.0 and Waitlist in people with Pedophilia, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedophilia
- What is being tested?
- Prevent It 2.0 and Waitlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteSweden
- Study dates
- 25 Nov 2022to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- concern about sexual urges regarding children
- Informed consent to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Pedophilia
- Being tested
- Prevent It 2.0, Waitlist
- Keywords
- Child sexual abuse, Pedophilic disorder, Preventive psychiatry, Internet based intervention, Cognitive behavioral therapy, Waitlist
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevent It 2.0Other
A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention
WaitlistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prevent It 2.0 | Experimental | Not described Receives: Other: Prevent It 2.0 |
| Waitlist | Active comparator | Not described Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 13 weeks
Secondary outcomes (1)
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).
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start25 Nov 2022
- Primary completion2 Oct 2024
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Principal investigator, Christoffer Rahm, Karolinska Institutet
- Investigators
- Christoffer Rahm, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663047
- Sponsor's protocol ID
- Prevent It 2.0/GPP
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in each respective article, after deidentification (text, tables, figures and appendices). Fully deidentified participant data will be shared in a public repository without demographic information. Data with demographic information will be shared with an approved data access agreement.
Publications
McMahan A, Joleby M, Andersson G, Letourneau EJ, Seto MC, Luke TJ, Rahm C. An international randomized waitlist-controlled trial of internet-delivered cognitive behavioral therapy for sexual urges toward children. J Consult Clin Psychol. 2026 Jul;94(7):425-436. doi: 10.1037/ccp0001019.
PubMed 42574102
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05663047
- Acronym / sponsor ID
- Prevent It 2.0/GPP
- Conditions
- Pedophilia
- Keywords
- Child sexual abuse, Pedophilic disorder, Preventive psychiatry, Internet based intervention, Cognitive behavioral therapy, Waitlist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre, Johns Hopkins Bloomberg School of Public Health
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control
| Arm | Type | Receives |
|---|---|---|
| Prevent It 2.0 | Experimental | Other: Prevent It 2.0 |
| Waitlist | Active comparator | Other: Waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- concern about sexual urges regarding children
- Informed consent to participate
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevent It 2.0A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention | Other | Prevent It 2.0 |
| WaitlistParticipants 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. | Other | Waitlist |
Primary outcome
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
Time frame: Up to 13 weeks
Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms.
1 secondary outcome
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?
Time frame: Up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 42574102McMahan A, Joleby M, Andersson G, Letourneau EJ, Seto MC, Luke TJ, Rahm C. An international randomized waitlist-controlled trial of internet-delivered cognitive behavioral therapy for sexual urges toward children. J Consult Clin Psychol. 2026 Jul;94(7):425-436. doi: 10.1037/ccp0001019.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in each respective article, after deidentification (text, tables, figures and appendices). Fully deidentified participant data will be shared in a public repository without demographic information. Data with demographic information will be shared with an approved data access agreement.
Related trials for Pedophilia
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia
Recruiting
Troubled-Desire & Therapeutic Chat for Reduction of CSAM Use (TD-CHAT)
Prevention, Well Being
Recruiting
ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use
Pedophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Rahm, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent It 2.0 and Waitlist in people with Pedophilia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.