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

NCT ID: NCT06852443

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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.

Detailed Description

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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. To compare the effectiveness in reducing CSAM behaviours between the TD only group and the waitlist group four weeks after the baseline assessment.
2. 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).

2\. 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.

Conditions

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Prevention Well Being Sexual Behavior Behavior Change Behavior Problems Behavior Change Interventions Child Sexual Abuse Material (CSAM) Consumption Behavioral Disorder Online Behaviour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* Randomized
* Multi-centre
* Open label
* Parallel assignment
* Superiority
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Selfhelp+TCS

Selfhelp modules followed by Therapist Chat Service

Group Type EXPERIMENTAL

Selfhelp modules

Intervention Type BEHAVIORAL

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 Service

Intervention Type BEHAVIORAL

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 modules

Selfhelp modules only

Group Type ACTIVE_COMPARATOR

Selfhelp modules

Intervention Type BEHAVIORAL

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)

TCS only

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

Group Type ACTIVE_COMPARATOR

Therapist Chat Service

Intervention Type BEHAVIORAL

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)

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Selfhelp modules

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)

Intervention Type BEHAVIORAL

Therapist Chat Service

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Hannes Gieseler

Dipl.Des.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité Universitätsmedizin Berlion

Berlin, , Germany

Site Status RECRUITING

Universitat Internacional de Catalunya (UIC), Catalonia, Spain

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Germany Spain

Facility Contacts

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Hannes Gieseler

Role: primary

+49(0)30450629318

Klaus M Beier, Prof. Dr. Dr.

Role: backup

+49(0)30450529301

Carlos García Forero, Prof.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32347899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27052851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18042300 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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8000502101

Identifier Type: -

Identifier Source: org_study_id

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