Observational StudyNCT07424872
Project VERANDA: Requirement Analysis Survey
An observational study of Observational Study, run by Berlin Institute of Health @ Charité at 1 site in Germany.
Trial summary
Between 0.6% and 22.2% of the global adult male population has a sexual interest in children (SIIC), depending on evaluation methods [1]. SIIC constitutes a major risk factor for child sexual abuse (CSA) and viewing of child sexual abuse material (CSAM). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Observational Study
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2025to 14 May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators do not assign participants to conditions, instead the investigators have different target groups: Groups that experience stigmatization: Individuals with a sexual interest in children Transgender and gender-diverse people Sex workers Healthcare workers Individuals who have experienced child sexual abuse Groups that provide services to stigmatized groups: Therapists for individuals with a sexual interest in children Therapists of transgender and gender-diverse individuals Therapists of sex workers Control/comparison group: General public
Who may be able to join
- Belonging to one of the target groups.
- Otherwise, for general members of the public, none.
Who cannot join
- Younger than 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Luke Flanagan, +4916092338142, luke.flanagan@bih-charite.de
About this study
Between 0.6% and 22.2% of the global adult male population has a sexual interest in children (SIIC), depending on evaluation methods [1]. SIIC constitutes a major risk factor for child sexual abuse (CSA) and viewing of child sexual abuse material (CSAM). The true rates of CSA offences cannot be estimated, but self-report studies find 30 times higher rates of child-reported CSA compared to reports from child protection services or police.
Engagement in therapy is a protective factor against the risk of child sexual abuse and can lead to reductions in CSAM consumption and severity. Anticipated negative therapist behaviour is associated with less willingness to seek treatment. The fear of being reported by the therapist discourages participation in therapy, a concern complicated by mandatory reporting laws in some countries. Negative attitudes towards ISIC are high, and SIIC may be the most stigmatised trait globally.
Read more
Identifying barriers to treatment for ISIC, and of measures to overcome them, is important to increase therapy engagement, with the goal to improve wellbeing, reduce CSAM consumption, and reduce the risk of CSA offences. Patient anonymity during therapy may play an important role in increasing disclosure of stigmatised traits. It remains unclear whether anonymous therapy addresses patient treatment anxieties and therefore increases the comfort or willingness to engage in therapy. To address this research gap, we conduct an anonymous online survey with ISIC to answer the following questions:
RQ1. Can online therapy preferences be identified for minor-attacted individuals and for their therapists?
RQ2. Are there individual factors that predict stigmatized individuals' online therapy preferences? (E.g. Trust, Self-Stigma)
RQ3. Are there differences between the different stigmatized groups', therapists, and general populations' online therapy preferences?
Read the detailed description
Participants will receive a study information that describes the aim of the project and a brief overview of data anonymization procedures. This study information is in simple English for comprehesability. Participants will have the option to access more detailed study information, explaining that privacy protections are implemented; tracking technologies are disabled; data will be encrypted and stored on Charité - Universitätsmedizin Berlin servers in compliance with the EU General Data Protection Regulation; and that anonymized data might be shared with academic research institutes within the project consortium. It is also stated that data could be stored for up to three years and that access will be restricted to project members only. To ensure accessibility and comprehensibility for diverse populations, the study information was additionally provided in an easy-to-understand language version. Participants are required to provide informed consent (collected via checkbox without personally-linkable ID) before participation. The questionnaire is available in both German and English.
Pilot testing was conducted prior to the main data collection, involving researchers and general members of the public who are not experts in the topic of the study. The pilot study evaluated the comprehensibility, sensitivity, clarity, and overall acceptability of the questionnaire items. In addition, technical functionality and user experience were informally tested across different individuals and devices.
This study was approved by the Institutional Ethics Committee of Charité - Universitätsmedizin Berlin (ID EA4_187_24).
The Charité data protection officewas consulted prior to the start of this study to ensure compliance with applicable data protection regulations, and their advise was implemented.
An instance of the survey tool SoSci Survey was hosted on Charité servers. Server-side IP logging disabled are disabled. Within SoSci Survey, cookies and IP-tracking are disabled, and a "Leave and delete my data" button is available for participants prior to final submission of their data. Participants are instructed not to provide any identifiable information either within the Survey or by email to the study team.
For preservation of anonymity, consent will be collected only via checkbox, and no records of individual identity were stored. To limit the identifiability of the data through data linkage, demographic information is limited to high-level information rather than specific information, such as country of residence rather than nationality, and age range rather than precise age. We also provide guidelines to participants about how to increase their privacy on the project website (https://project-veranda.github.io/VERANDA/news/How_to_protect_your_identity/) online. To the best of our efforts, this survey will be conducted anonymously.
- Conditions
- Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with a sexual interest in children | Not described | |
| Transgender and gender-diverse people | Not described | |
| Sex workers | Not described | |
| Healthcare workers | Not described | |
| Individuals who have experienced child sexual abuse | Not described | |
| Therapists for individuals with a sexual interest in children | Not described | |
| Therapists of transgender and gender-diverse individuals | Not described | |
| Therapists of sex workers | Not described | |
| General public | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferences of design features
RQ1.1 Can preferences of design features for an online therapy tool be identified for minor-attacted individuals and for their therapists?
RQ3.4 Are there differences between the different groups in the preferred choice of consultation technology?
Preferences of design features for an online therapy tool: 7-point Likert scale.
Measured: May 2025 - May 2026
Secondary outcomes (1)
Preferred choice of consultation method
RQ1.2 Can the preferred choice of consultation method be identified?
RQ2.3 Does self-stigma, treatment anxiety or trust influence the preferred choice of consultation method?
RQ3.3 Are there differences between the different groups in the preferred choice of consultation method?
In-person or anonymously online; Individual therapy or group therapy: 7-point bi-directional Likert scale. Responses will be dichotomized into two categories (e.g., "prefer 1-to-1" vs. "prefer group therapy") with neutral responses excluded from the analysis. This results in binary outcome variables.
Measured: May 2025 - May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start13 May 2025
- Primary completion14 May 2026 (estimated)
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Observational StudyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin Institute of Health @ Charité
- Sponsor type
- University, hospital or other
- Collaborators
- Fraunhofer Institute for Applied and Integrated Security AISEC, Deutsches Forschungszentrum für Künstliche Intelligenz GmbH (DFKI), Technische Universität Berlin, Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424872
- Sponsor's protocol ID
- VERANDA: Requirement Analysis
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fear NT, Seddon R, Jones N, Greenberg N, Wessely S. Does anonymity increase the reporting of mental health symptoms? BMC Public Health. 2012 Sep 17;12:797. doi: 10.1186/1471-2458-12-797.
PubMed 22985427Jahnke S, Imhoff R, Hoyer J. Stigmatization of people with pedophilia: two comparative surveys. Arch Sex Behav. 2015 Jan;44(1):21-34. doi: 10.1007/s10508-014-0312-4. Epub 2014 Jun 20.
PubMed 24948422Edwards W, Hensley C. Contextualizing Sex Offender Management Legislation and Policy: Evaluating the Problem of Latent Consequences in Community Notification Laws. Int J Offender Ther Comp Criminol. 2001 Feb 1;45(1):83-101.
Grady MD, Levenson JS, Mesias G, Kavanagh S, Charles J. "I can't talk about that": Stigma and fear as barriers to preventive services for minor-attracted persons. Stigma and Health. 2019;4(4):400-10.
Jahnke S, McPhail IV, Antfolk J. Stigma processes, psychological distress, and attitudes toward seeking treatment among pedohebephilic people. PLoS One. 2024 Oct 24;19(10):e0312382. doi: 10.1371/journal.pone.0312382. eCollection 2024.
PubMed 39446727Schuler M, Gieseler H, Schweder KW, von Heyden M, Beier KM. Characteristics of the Users of Troubled Desire, a Web-Based Self-management App for Individuals With Sexual Interest in Children: Descriptive Analysis of Self-assessment Data. JMIR Ment Health. 2021 Feb 19;8(2):e22277. doi: 10.2196/22277.
PubMed 33605895Van Deinse TB, Cuddeback GS, Wilson AB, Edwards D Jr, Lambert M. Variation in Criminogenic Risks by Mental Health Symptom Severity: Implications for Mental Health Services and Research. Psychiatr Q. 2021 Mar;92(1):73-84. doi: 10.1007/s11126-020-09782-x.
PubMed 32458340Beier KM, Grundmann D, Kuhle LF, Scherner G, Konrad A, Amelung T. The German Dunkelfeld project: a pilot study to prevent child sexual abuse and the use of child abusive images. J Sex Med. 2015 Feb;12(2):529-42. doi: 10.1111/jsm.12785. Epub 2014 Dec 4.
PubMed 25471337Stoltenborgh M, van Ijzendoorn MH, Euser EM, Bakermans-Kranenburg MJ. A global perspective on child sexual abuse: meta-analysis of prevalence around the world. Child Maltreat. 2011 May;16(2):79-101. doi: 10.1177/1077559511403920. Epub 2011 Apr 21.
PubMed 21511741Savoie V, Quayle E, Flynn E. Prevalence and correlates of individuals with sexual interest in children: A systematic review. Child Abuse Negl. 2021 May;115:105005. doi: 10.1016/j.chiabu.2021.105005. Epub 2021 Mar 7.
PubMed 33691252
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project VERANDA: Requirement Analysis Survey
- ClinicalTrials.gov ID
- NCT07424872
- Acronym / sponsor ID
- VERANDA: Requirement Analysis
- Conditions
- Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Berlin Institute of Health @ CharitéUniversity, hospital or other
- Collaborators
- Fraunhofer Institute for Applied and Integrated Security AISEC, Deutsches Forschungszentrum für Künstliche Intelligenz GmbH (DFKI), Technische Universität Berlin, Charite University, Berlin, Germany
- Study start
- 13 May 2025 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 20 Feb 2026 (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.
Between 0.6% and 22.2% of the global adult male population has a sexual interest in children (SIIC), depending on evaluation methods [1]. SIIC constitutes a major risk factor for child sexual abuse (CSA) and viewing of child sexual abuse material (CSAM). The true rates of CSA offences cannot be estimated, but self-report studies find 30 times higher rates of child-reported CSA compared to reports from child protection services or police.
Engagement in therapy is a protective factor against the risk of child sexual abuse and can lead to reductions in CSAM consumption and severity. Anticipated negative therapist behaviour is associated with less willingness to seek treatment. The fear of being reported by the therapist discourages participation in therapy, a concern complicated by mandatory reporting laws in some countries. Negative attitudes towards ISIC are high, and SIIC may be the most stigmatised trait globally.
Identifying barriers to treatment for ISIC, and of measures to overcome them, is important to increase therapy engagement, with the goal to improve wellbeing, reduce CSAM consumption, and reduce the risk of CSA offences. Patient anonymity during therapy may play an important role in increasing disclosure of stigmatised traits. It remains unclear whether anonymous therapy addresses patient treatment anxieties and therefore increases the comfort or willingness to engage in therapy. To address this research gap, we conduct an anonymous online survey with ISIC to answer the following questions:
RQ1. Can online therapy preferences be identified for minor-attacted individuals and for their therapists?
RQ2. Are there individual factors that predict stigmatized individuals' online therapy preferences? (E.g. Trust, Self-Stigma)
RQ3. Are there differences between the different stigmatized groups', therapists, and general populations' online therapy preferences?
Detailed description
Participants will receive a study information that describes the aim of the project and a brief overview of data anonymization procedures. This study information is in simple English for comprehesability. Participants will have the option to access more detailed study information, explaining that privacy protections are implemented; tracking technologies are disabled; data will be encrypted and stored on Charité - Universitätsmedizin Berlin servers in compliance with the EU General Data Protection Regulation; and that anonymized data might be shared with academic research institutes within the project consortium. It is also stated that data could be stored for up to three years and that access will be restricted to project members only. To ensure accessibility and comprehensibility for diverse populations, the study information was additionally provided in an easy-to-understand language version. Participants are required to provide informed consent (collected via checkbox without personally-linkable ID) before participation. The questionnaire is available in both German and English.
Pilot testing was conducted prior to the main data collection, involving researchers and general members of the public who are not experts in the topic of the study. The pilot study evaluated the comprehensibility, sensitivity, clarity, and overall acceptability of the questionnaire items. In addition, technical functionality and user experience were informally tested across different individuals and devices.
This study was approved by the Institutional Ethics Committee of Charité - Universitätsmedizin Berlin (ID EA4_187_24).
The Charité data protection officewas consulted prior to the start of this study to ensure compliance with applicable data protection regulations, and their advise was implemented.
An instance of the survey tool SoSci Survey was hosted on Charité servers. Server-side IP logging disabled are disabled. Within SoSci Survey, cookies and IP-tracking are disabled, and a "Leave and delete my data" button is available for participants prior to final submission of their data. Participants are instructed not to provide any identifiable information either within the Survey or by email to the study team.
For preservation of anonymity, consent will be collected only via checkbox, and no records of individual identity were stored. To limit the identifiability of the data through data linkage, demographic information is limited to high-level information rather than specific information, such as country of residence rather than nationality, and age range rather than precise age. We also provide guidelines to participants about how to increase their privacy on the project website (https://project-veranda.github.io/VERANDA/news/How_to_protect_your_identity/) online. To the best of our efforts, this survey will be conducted anonymously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Individuals with a sexual interest in children | – | – |
| Transgender and gender-diverse people | – | – |
| Sex workers | – | – |
| Healthcare workers | – | – |
| Individuals who have experienced child sexual abuse | – | – |
| Therapists for individuals with a sexual interest in children | – | – |
| Therapists of transgender and gender-diverse individuals | – | – |
| Therapists of sex workers | – | – |
| General public | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators do not assign participants to conditions, instead the investigators have different target groups: Groups that experience stigmatization: Individuals with a sexual interest in children Transgender and gender-diverse people Sex workers Healthcare workers Individuals who have experienced child sexual abuse Groups that provide services to stigmatized groups: Therapists for individuals with a sexual interest in children Therapists of transgender and gender-diverse individuals Therapists of sex workers Control/comparison group: General public
Key inclusion criteria (2 listed)
- Belonging to one of the target groups.
- Otherwise, for general members of the public, none.
Key exclusion criteria (1 listed)
- Younger than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preferences of design features
Time frame: May 2025 - May 2026
RQ1.1 Can preferences of design features for an online therapy tool be identified for minor-attacted individuals and for their therapists? RQ3.4 Are there differences between the different groups in the preferred choice of consultation technology? Preferences of design features for an online therapy tool: 7-point Likert scale.
1 secondary outcome
Preferred choice of consultation method
Time frame: May 2025 - May 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 22985427Fear NT, Seddon R, Jones N, Greenberg N, Wessely S. Does anonymity increase the reporting of mental health symptoms? BMC Public Health. 2012 Sep 17;12:797. doi: 10.1186/1471-2458-12-797.
- Results publication: PubMed 24948422Jahnke S, Imhoff R, Hoyer J. Stigmatization of people with pedophilia: two comparative surveys. Arch Sex Behav. 2015 Jan;44(1):21-34. doi: 10.1007/s10508-014-0312-4. Epub 2014 Jun 20.
- Results publicationEdwards W, Hensley C. Contextualizing Sex Offender Management Legislation and Policy: Evaluating the Problem of Latent Consequences in Community Notification Laws. Int J Offender Ther Comp Criminol. 2001 Feb 1;45(1):83-101.
- Results publicationGrady MD, Levenson JS, Mesias G, Kavanagh S, Charles J. "I can't talk about that": Stigma and fear as barriers to preventive services for minor-attracted persons. Stigma and Health. 2019;4(4):400-10.
- Results publication: PubMed 39446727Jahnke S, McPhail IV, Antfolk J. Stigma processes, psychological distress, and attitudes toward seeking treatment among pedohebephilic people. PLoS One. 2024 Oct 24;19(10):e0312382. doi: 10.1371/journal.pone.0312382. eCollection 2024.
- Results publication: PubMed 33605895Schuler M, Gieseler H, Schweder KW, von Heyden M, Beier KM. Characteristics of the Users of Troubled Desire, a Web-Based Self-management App for Individuals With Sexual Interest in Children: Descriptive Analysis of Self-assessment Data. JMIR Ment Health. 2021 Feb 19;8(2):e22277. doi: 10.2196/22277.
- Results publication: PubMed 32458340Van Deinse TB, Cuddeback GS, Wilson AB, Edwards D Jr, Lambert M. Variation in Criminogenic Risks by Mental Health Symptom Severity: Implications for Mental Health Services and Research. Psychiatr Q. 2021 Mar;92(1):73-84. doi: 10.1007/s11126-020-09782-x.
- Results publication: PubMed 25471337Beier KM, Grundmann D, Kuhle LF, Scherner G, Konrad A, Amelung T. The German Dunkelfeld project: a pilot study to prevent child sexual abuse and the use of child abusive images. J Sex Med. 2015 Feb;12(2):529-42. doi: 10.1111/jsm.12785. Epub 2014 Dec 4.
- Results publication: PubMed 21511741Stoltenborgh M, van Ijzendoorn MH, Euser EM, Bakermans-Kranenburg MJ. A global perspective on child sexual abuse: meta-analysis of prevalence around the world. Child Maltreat. 2011 May;16(2):79-101. doi: 10.1177/1077559511403920. Epub 2011 Apr 21.
- Results publication: PubMed 33691252Savoie V, Quayle E, Flynn E. Prevalence and correlates of individuals with sexual interest in children: A systematic review. Child Abuse Negl. 2021 May;115:105005. doi: 10.1016/j.chiabu.2021.105005. Epub 2021 Mar 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational Study, run by Berlin Institute of Health @ Charité at 1 site in Germany.
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 1 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 13 Mar 2026. 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 Germany. 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?
Contact Prof. Dr.-Ing Poikela (30 450 528 786 ext. +49, maija.poikela@bih-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferences of design features (time frame: May 2025 - May 2026). 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 NCT07424872, which also lists 10 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 13 Mar 2026.