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PreventionTD-CHATNCT06852443

Troubled-Desire & Therapeutic Chat for Reduction of CSAM Use (TD-CHAT)

A study testing Selfhelp modules and Therapist Chat Service in people with Prevention and Well Being, run by Charite University, Berlin, Germany at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Prevention, Well Being, Sexual Behavior
What is being tested?
Selfhelp modules and Therapist Chat Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesin 2 countries
Study dates
1 Apr 2025to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

Germany1 site, 1 recruiting

  • Charité Universitätsmedizin Berlion

    Berlin, 10117

    Hannes Gieseler, +49(0)30450629318, hannes.gieseler@charite.de

    Klaus M Beier, Prof. Dr. Dr., +49(0)30450529301, klaus.beier@charite.de

    Recruiting

Other trials in Germany

Spain1 site, 1 recruiting

  • Universitat Internacional de Catalunya (UIC), Catalonia, Spain

    Barcelona

    Carlos García Forero, Prof., cgarciaf@uic.es

    Not yet recruiting

Other trials in Spain

About this study

Official title: Troubled Desire & Therapeutic Chat for Reduction of CSAM Use

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. 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. 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.
Read more

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.

Read the detailed description

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
  2. To compare the effectiveness in reducing CSAM behaviours between the TD only group and the waitlist group four weeks after the baseline assessment.
  3. To compare the post-intervention effectiveness in reducing CSAM behaviours of the Selfhelp modules versus TCS alone and Selfhelp modules followed by TCS.

1.2 Secondary objectives

  1. To assess the reduction in severity, time and self-rated risk of CSAM consumption among participants in the intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) compared to the waitlist control group, at post-intervention.
  2. To compare the impact of the interventions (Selfhelp modules, TCS, or Selfhelp + TCS) on mental wellbeing, in contrast to the control group, at the end of the intervention period.
  3. To evaluate the effect of the interventions (Selfhelp modules, TCS, or Selfhelp + TCS) on total sexual outlet compared with the waitlist control group after the intervention period.
  4. To identify any adverse effects associated with the interventions (Selfhelp modules, TCS, or Selfhelp + TCS).
  5. Hypotheses

2.1 Primary hypothesis

  1. Participants in the Selfhelp-only 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. 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.

2.2 Secondary hypothesis

  1. Participants in the intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) will show a statistically significant reduction in the severity, time and self-rated risk of CSAM consumption compared to participants in the waitlist control group, four weeks after the initial intervention. Among the intervention groups, it is expected that the Selfhalp + TCS group will show the greatest reduction in CSAM consumption, followed by the TCS group and then the Selfhelp-only group.
  2. Participants in the intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) will show a statistically significant improvement in their mental well-being (measured using the Warwick-Edinburgh Mental Wellbeing scale). compared to participants in the waitlist control group, at post-intervention. Among the intervention groups, the Selfhelp + TCS group is expected to show the greatest improvement, followed by the TCS group, and then the Selfhelp-only group.
  3. Participants in the intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) will show a statistically significant reduction in total sexual outlet (measured using a self-reported measure) compared to participants in the waitlist control group, after the intervention. Among the intervention groups, the Selfhelp + TCS group is expected to show the greatest reduction, followed by the TCS group, and then the Selfhelp-only group.
  4. All intervention groups (Selfhelp modules, TCS, or Selfhelp + TCS) will experience adverse effects (psychological and emotional distress) to a similar extent, with no significant differences in the number or type of adverse effects reported. Adverse effects are expected to primarily involve mild to moderate psychological and emotional distress, such as feelings of anxiety or frustration, but are not expected to lead to severe distress or long-term harm.

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.

Being tested
Selfhelp modules, Therapist Chat Service
Keywords
Child Sexual Abuse Material (CSAM) consumption, CSAM, Child Sexual Abuse, Digital online intervention, CSA, CBT, iCBT, Cognitive Behavioural Therapy, Pedophilia, chat Intervention
Medical subject headings
Sexual Behavior, Mental Disorders, Pedophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selfhelp modulesBehavioural

    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)

  • Therapist Chat ServiceBehavioural

    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)

Study groups in NCT06852443
Study groupRoleWhat they receive
Selfhelp+TCSExperimentalSelfhelp modules followed by Therapist Chat Service
Receives: Behavioral: Selfhelp modules; Behavioral: Therapist Chat Service
Selfhelp modulesActive comparatorSelfhelp modules only
Receives: Behavioral: Selfhelp modules
TCS onlyActive comparator4-6 Sessions text message-based Therapist Chat Service only
Receives: Behavioral: Therapist Chat Service
WaitlistNo interventionParticipants will remain on a waitlist for the first two weeks without receiving any kind of intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Child Sexual Abuse Material (RCSAM) severity

    1. 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.

    Measured: every 2 weeks for 12 weeks after onboarding

  2. Reduction in Child Sexual Abuse Material (RCSAM) time

    1. 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.

    Measured: every 2 weeks for 12 weeks after onboarding

  3. Reduction in Child Sexual Abuse Material (RCSAM) risk

    1. 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.

    Measured: every 2 weeks for 12 weeks after onboarding

Secondary outcomes (4)

  1. 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.

    Measured: baseline and 12 weeks after onboarding

  2. 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.

    Measured: baseline and every 2 weeks for 12 weeks after onboarding

  3. 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.

    Measured: baseline and every 2 weeks during 12 weeks after onboarding

  4. 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.

    Measured: baseline and every 2 weeks during 12 weeks after onboarding

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start1 Apr 2025
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
* Randomized * Multi-centre * Open label * Parallel assignment * Superiority
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852443
Sponsor's protocol ID
8000502101
Acronym
TD-CHAT
Status last verified
Apr 2025
First submitted
19 Feb 2025
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 32347899

  • 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.

    PubMed 27052851

  • 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.

    PubMed 18042300

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

Questions about this trial

What is this clinical trial studying?

A study testing Selfhelp modules and Therapist Chat Service in people with Prevention and Well Being, run by Charite University, Berlin, Germany at 2 sites in 2 countries.

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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Child Sexual Abuse Material (RCSAM) severity (time frame: every 2 weeks for 12 weeks after onboarding). The study lists 3 primary outcomes in all. 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 NCT06852443, which also lists 4 linked publications.

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 7 May 2025.

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