- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424872
Project VERANDA: Requirement Analysis Survey
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?
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Prof. Dr.-Ing Poikela
- Phone Number: +49 30 450 528 786
- Email: maija.poikela@bih-charite.de
Study Locations
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State of Berlin
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Berlin, State of Berlin, Germany, 10117
- Recruiting
- Charité - Universitätsmedizin Berlin
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Contact:
- Luke Flanagan
- Phone Number: +4916092338142
- Email: luke.flanagan@bih-charite.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- Belonging to one of the target groups.
- Otherwise, for general members of the public, none.
Exclusion Criteria:
- Younger than 18
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthcare workers
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Individuals with a sexual interest in children
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Transgender and gender-diverse people
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Sex workers
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Individuals who have experienced child sexual abuse
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Therapists for individuals with a sexual interest in children
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Therapists of transgender and gender-diverse individuals
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Therapists of sex workers
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General public
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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. |
May 2025 - May 2026
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferred choice of consultation method
Time Frame: May 2025 - May 2026
|
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. |
May 2025 - May 2026
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferred choice of consultation technology
Time Frame: May 2025 - May 2026
|
RQ2.4 Does self-stigma, treatment anxiety or trust influence the preferred choice of consultation technology? (text-only, audio-only, or video and audio; Smartphone or laptop; App or browser extension): 7-point bi-directional Likert scale (e.g., preference for laptop vs. smartphone). Responses will be dichotomized into two categories (e.g., "prefer laptop" vs. "prefer smartphone"), with neutral responses excluded from the analysis. This results in binary outcome variables. |
May 2025 - May 2026
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Preference of having PETs for an online therapy tool
Time Frame: May 2025 - May 2026
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RQ2.2 Do preferences of having PETs for an online therapy tool vary based on self-stigma, treatment anxiety, or trust? RQ3.2 Do preferences of having PETs for an online therapy tool vary between different groups? Preferences for using various privacy-enhancing technologies (PETs) in online therapy will be measured with multiple items on a 7-point Likert scale. An exploratory factor analysis (EFA) will be conducted to examine the underlying structure. Based on the factor solution, items loading on a common factor will be combined to create a composite score. |
May 2025 - May 2026
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Willingness to engage in therapy
Time Frame: May 2025 - May 2026
|
RQ2.1.1 Does self-stigma, treatment anxiety, or trust influence willingness to engage in non-anonymous online therapy? RQ2.1.2 Does self-stigma, treatment anxiety, or trust influence willingness to engage in anonymous online therapy? RQ2.1.3 Does self-stigma, treatment anxiety, or trust influence willingness to engage in in-person therapy? RQ3.1.1 Are there differences between the different groups in willingness to engage in non-anonymous online therapy? RQ3.1.2 Are there differences between the different groups in willingness to engage in anonymous online therapy? RQ3.1.3 Are there differences between the different groups in willingness to engage in-person therapy? 3-Point scale that will be categorized into two binary categories, willingness to engage or unwillingness. Willingness to engage in specific therapy methods (anonymous online, non-anonymous online, in-person) is measured on a 3-point Likert Scale. |
May 2025 - May 2026
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Communication cue importance for effective therapy
Time Frame: May 2025 - May 2026
|
7-point Likert Scale Audio cues (E.g. Accent, slang) Visual cues (E.g. Manner of dress, body language) Written cues (E.g. Slang, Specific word choice) |
May 2025 - May 2026
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Treatment-Related Anxieties
Time Frame: May 2025 - May 2026
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What fears and concerns do potential users have regarding participating in (digital) therapy?
(groups: stigmatized groups, therapists, general public; descriptive statistics: means, SD).
We look at individual measures on the Treatment Anxieties Questionnaire, rather than a sum score, with the addition of a question relating to concerns of being prosecuted by law enforcement.
|
May 2025 - May 2026
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Are there mediums or media sources that an average prospective patient is more willing to trust?
Time Frame: May 2025 - May 2026
|
We will report descriptive statistics (mean, standard deviation) for each of the mediums or media and examine for statistical difference between them using a 1-way Kruskal-Wallis test. If statistical differences are found, we will further examine for significant differences with a Matt-Whitney U-Test for pairwise comparison. Are there other factors that influence a prospective patient's decision to download and use a healthcare tool? Responses given in the free text box will be coded by theme or avenue and reported descriptively. |
May 2025 - May 2026
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Which cues are important to be preserved from anonymization (or otherwise sufficiently accurately conveyed) for a therapist to be able to provide therapy?
Time Frame: May 2025 - May 2026
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All cues will be measured with descriptive statistics (mean, standard deviation).
This will only be measured for therapists, prospective patients were not asked this question.
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May 2025 - May 2026
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Level of acceptable body-language and facial expression communication
Time Frame: May 2025 - May 2026
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Is there a preference in terms of body-language and facial expression display, either preferring no expression to be displayed, only facial expressions, or also body language?
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May 2025 - May 2026
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Browser Extension or Independent App
Time Frame: May 2025 - May 2026
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Is there a preference between the toolset being available as a browser extension or as an app?
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May 2025 - May 2026
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What are therapists' opinions regarding anonymization and anonymity in (psycho)therapy?
Time Frame: May 2025 - May 2026
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6.1 - 6.2: These will be reported using descriptive statistics (mean, standard deviation) for therapists data only. 6.3: We will conduct an Explorative Factor Analysis to generate factors like e.g. the anonymity feature preference score for both MAP and MAP therapists. Then, we will use Mann-Whitney U-Test to test for significant differences. |
May 2025 - May 2026
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Collaborators and Investigators
Publications and helpful links
General 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.
- Jahnke 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.
- Edwards 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.
- Schuler 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.
- Van 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.
- Beier 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.
- Stoltenborgh 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.
- Savoie 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VERANDA: Requirement Analysis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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