NCT06852443

Brief Summary

The goal of this prospective multicentred, stratified, parallel-group superiority study is to prevent and reduce the usage of Child Sexual Abuse Material (CSAM) by a Therapist Chat Service (TCS) and Selfhelp Platform for Self-Referred Patients, mostly men with a sexual interest in children. The interventions are based on Cognitive Behavioral Therapy (CBT) principles and designed to treat the sexual behavioral disorder related with CSAM consumption.

  1. 1.Participants in the Selfhelp modules group will show a statistically significantly higher proportion of reduction in CSAM behaviours four weeks after baseline, as compared to participants in the waitlist control group.
  2. 2.Participants in the Selfhelp modules followed by TCS group will show a statistically significantly higher reduction of CSAM behaviours compared to participants in the Selfhelp-only and TCS-only groups, post-intervention.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2025Jul 2026

First Submitted

Initial submission to the registry

February 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

February 19, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

Child Sexual Abuse Material (CSAM) consumptionCSAMChild Sexual AbuseDigital online interventionCSACBTiCBTCognitive Behavioural TherapyPedophiliachat Intervention

Outcome Measures

Primary Outcomes (3)

  • Reduction in Child Sexual Abuse Material (RCSAM) severity

    A) Reduction in Child Sexual Abuse Material severity (RCSAM severity): A reduction in CSAM severity in the last 2 weeks, defined as the pre-post difference in highest "Combating Paedophile Information Networks in Europe" (COPINE) scale scores, with a reduction from severity levels 4 or higher to levels 3 or lower after the intervention.

    every 2 weeks for 12 weeks after onboarding

  • Reduction in Child Sexual Abuse Material (RCSAM) time

    B) Reduction in Child Sexual Abuse Material time (RCSAM time): A 50% or greater decrease in CSAM consumption time (minutes) over the past 2 weeks. CSAM time is measured as the time (in minutes) spent consuming CSAM materials over the past 2 weeks.

    every 2 weeks for 12 weeks after onboarding

  • Reduction in Child Sexual Abuse Material (RCSAM) risk

    C) Reduction in self-reported risk of Child Sexual Abuse Material use (RCSAM risk): A reduction in self-reported risk of CSAM use (RCSAM risk): A decrease in the risk of CSAM consumption over the last 2 weeks, defined as a pre-post decrease in self-reported risk, as measured using an adapted version of the "Sexual Child Molestation Risk Assessment" (SChiMRA+) Part A.

    every 2 weeks for 12 weeks after onboarding

Secondary Outcomes (4)

  • Risk of Child Sexual Abuse Material (CSAM) consumption

    baseline and 12 weeks after onboarding

  • Frequency of Child Sexual Abuse Material (CSAM) consumption

    baseline and every 2 weeks for 12 weeks after onboarding

  • Mental Wellbeing

    baseline and every 2 weeks during 12 weeks after onboarding

  • Total Sexual Outlet

    baseline and every 2 weeks during 12 weeks after onboarding

Study Arms (4)

Selfhelp+TCS

EXPERIMENTAL

Selfhelp modules followed by Therapist Chat Service

Behavioral: Selfhelp modulesBehavioral: Therapist Chat Service

Selfhelp modules

ACTIVE COMPARATOR

Selfhelp modules only

Behavioral: Selfhelp modules

TCS only

ACTIVE COMPARATOR

4-6 Sessions text message-based Therapist Chat Service only

Behavioral: Therapist Chat Service

Waitlist

NO INTERVENTION

Participants will remain on a waitlist for the first two weeks without receiving any kind of intervention.

Interventions

16 web-based structured selfhelp modules, based on CBT techniques from the Berlin Dissexuality Therapy (Beier, K. M. (2021). Pedophilia, hebephilia and sexual offending against children. The Berlin Dissexuality Therapy (BEDIT). Springer)

Selfhelp modulesSelfhelp+TCS

Online Therapy Chat Service (TCS) based on CBT techniques from the Berlin Dissexuality Therapy (Beier, K. M. (2021). Pedophilia, hebephilia and sexual offending against children. The Berlin Dissexuality Therapy (BEDIT). Springer)

Selfhelp+TCSTCS only

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participant (≥18 years);
  • recent (last 2 weeks) CSAM use or past CSAM use and self-reported risk;
  • proficiency in English, German or Spanish;
  • voluntary participation and agreement to the terms of the study.

You may not qualify if:

  • Severe neuropsychiatric comorbidities (unstable psychotic disorder, organic brain damage, diminished intellectual functioning, untreated drug or alcohol addiction);
  • history of contact CSA perpetration (past or present);
  • ongoing criminal investigation, trial, punishment, or probation status for online or offline CSA or CSAM use;
  • current inpatient psychiatric treatment or other concurrent treatment targeting CSAM behaviours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Universitätsmedizin Berlion

Berlin, 10117, Germany

RECRUITING

Universitat Internacional de Catalunya (UIC), Catalonia, Spain

Barcelona, Spain

NOT YET RECRUITING

Related Publications (4)

  • Landgren V, Malki K, Bottai M, Arver S, Rahm C. Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):897-905. doi: 10.1001/jamapsychiatry.2020.0440.

    PMID: 32347899BACKGROUND
  • Merdian HL, Moghaddam N, Boer DP, Wilson N, Thakker J, Curtis C, Dawson D. Fantasy-Driven Versus Contact-Driven Users of Child Sexual Exploitation Material: Offender Classification and Implications for Their Risk Assessment. Sex Abuse. 2018 Apr;30(3):230-253. doi: 10.1177/1079063216641109. Epub 2016 Apr 6.

    PMID: 27052851BACKGROUND
  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND
  • Quayle, E. (2008). The COPINE project. Irish Probation Journal, 5(9), 65-83.

    BACKGROUND

MeSH Terms

Conditions

Sexual BehaviorMental DisordersPedophilia

Condition Hierarchy (Ancestors)

BehaviorParaphilic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: * Randomized * Multi-centre * Open label * Parallel assignment * Superiority
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl.Des.

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 28, 2025

Study Start

April 1, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations