An interventional study of Selfhelp modules and Therapist Chat Service in Prevention, Well Being and Sexual Behavior, sponsored by Charite University, Berlin, Germany. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Prevention
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.
Researchers will compare TCS-only-, Selfhelp-only-, Selfhelp + TCS- and Waiting group to see if if the interventions decrease CSAM use and improve mental well-being.
Participants will get web based selfhelp-modules and/or text-based chat intervention operated by trained therapists.
The study will evaluate whether the TCS intervention and Selfhelp modules, independently or combined, effectively reduce CSAM use or risk of CSAM consumption and improve mental well-being among self-referred participants.
1. Objectives 1.1 Primary objectives
1.2 Secondary objectives
2. Hypotheses
2.1 Primary hypothesis
2.2 Secondary hypothesis
3.Trial design
This is a prospective, randomised, multicentre, open-label, parallel-group, superiority trial designed to compare stratified, pair-matched CSAM users across three intervention groups and one wait-list control group, with an allocation ratio of 1:1:1:1. Following participant agreement to the terms of the study, demographic information, measures for stratified randomization, and baseline outcome data will be collected. Additionally, data collected from the four groups Selfhelp modules, TCS, Selfhelp + TCS, and waitlist) of the TD-CHAT study will be compared with data from a fifth group (waitlist + TCS) sourced from the "Scalable Technology for Online Prevention of Child Sexual Abuse and Child Sexual Abuse Materials" (STOP-CSAM) project.
52 studies on the registry are indexed under Sexual Behavior; 21 are open to participants now.
This study's planned enrollment of 180 is below the median of 234 across 43 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
Selfhelp modules followed by Therapist Chat Service
Behavioral: Selfhelp modules · Behavioral: Therapist Chat Service
Selfhelp modules only
Behavioral: Selfhelp modules
4-6 Sessions text message-based Therapist Chat Service only
Behavioral: Therapist Chat Service
Participants will remain on a waitlist for the first two weeks without receiving any kind of intervention.
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)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: every 2 weeks for 12 weeks after onboarding
Risk of Child Sexual Abuse Material (CSAM) consumption
Risk of CSAM consumption: Sexual Child Molestation Risk Assessment (SchiMRA+ part A) at baseline and follow-up.
Time frame: baseline and 12 weeks after onboarding
Frequency of Child Sexual Abuse Material (CSAM) consumption
Frequency of Child Sexual Abuse Material (CSAM) consumption: Self-reported every two weeks, at baseline and follow-up.
Time frame: baseline and every 2 weeks for 12 weeks after onboarding
Mental Wellbeing
Mental wellbeing: The Warwick-Edinburgh Mental Wellbeing Scale (WEMBWS; Tennant et al., 2007). The total score is obtained by summing the score for each of the 14 items. The scoring range for each item is from 1 - 5 and the total score is from 14-70. Higher scores mean a better outcome. Mental wellbeing is measured over the past 2 weeks.
Time frame: baseline and every 2 weeks during 12 weeks after onboarding
Total Sexual Outlet
1. Self-reported number of orgasms achieved from masturbation using Child Sexual Abuse Material (CSAM) in the past week 2. Self-reported number of orgasms achieved from masturbation not using CSAM in the past week 3. Self-reported number of orgasms achieved from sexual interaction in the past week 4. Total sexual outlet: sum of self-reported number of orgasms from masturbation (with and without using CSAM) + self-reported number of orgasms from sexual interaction. This outcome is measured at baseline and follow-up.
Time frame: baseline and every 2 weeks during 12 weeks after onboarding
Plan to share: Yes
Started Apr 2025 (actual). Primary completion is estimated for Feb 2026, 10 months after the start.
Of 31 interventional studies with no phase under Sexual Behavior, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 59. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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Charite University, Berlin, Germany →