Information for research subject
We want to ask you if you would like to participate in our current research project, an Internet-based cognitive behavioral therapy (CBT) to reduce the risk of committing sexual abuse against children. In this document you will receive information about the project and what it means to participate.
What kind of project is it and why do you want me to participate?
There is a great need for more knowledge about how to help people who are concerned about their sexual urges, feelings or behaviors regarding children. This research project aims to evaluate a psychological treatment method with the goal of helping people gain an increased understanding of and control over their own thoughts, feelings and behaviors.
You are being asked to participate because you are concerned about your sexual urges regarding children, wish to receive help with this and have shown an interest in participating in the study.
The research lead for the project is the Karolinska Institutet. Research principal means the organization responsible for the project. The application has been approved by the Ethics Review Authority, Dnr 2022-03938-01.
How does the project work?
In this study, we test an Internet-based, therapist-assisted, psychotherapy treatment that in a previous clinical study was shown to be effective in reducing problematic sexual behaviors directed at children.
Initially, you will undergo an intake interview with a researcher. The interview is conducted either via written chat or voice call on a secure platform where you are completely anonymous. The purpose of the interview is for you to have any questions about the study answered and for the researcher to check that you meet the criteria for participation. The researcher will also ask questions about your mental health. The intake interview takes about an hour. If you meet the criteria, you will be asked to provide your consent to participate.
When you have been admitted to the study, you will have to fill in some forms with questions about sexuality, mental health, social situation and information about any previous convictions. Estimated time for this is about 1 hour.
Half of the participants will then have direct access to the treatment, half will be randomized (i.e. randomly distributed) to be placed on a waiting list for thirteen weeks before starting treatment. While you are on the waiting list, you have to answer questions about any ongoing problematic sexual behavior.
The treatment is based on cognitive behavioral therapy (CBT) and lasts for nine weeks. The treatment is self-paced, which means that you can carry out the treatment in a flexible way, when it suits you, at any time of the day. You don't have to take time off from work or studies. The treatment is free. You need a computer or a smart phone to access the platform where you report the results of your home exercises and receive personal feedback from your therapist. Your participation is anonymous and the platform is also accessible via the tor browser.
The treatment consists of nine modules. Each module contains a shorter introductory video (1-2 minutes), information and instructions, homework and the possibility to contact your therapist through a message function on the platform. Your work on each module, including watching the videos and reporting experiences from the previous week's module, is around 1-2 hours a week. After finishing treatment and four weeks after finishing treatment, you will be asked to fill in a few more forms as follow-up measurements, estimated time approx. 1.5 hours. Total time for study participation is approximately 16 hours.
On some occasions we will ask you to report links to websites that contain child sexual abuse material if you know of any such, as well as provide us with information if you know of any children or young people who you believe are at risk of being abused or harmed in any way.
Possible consequences and risks of participating in the project
The questionnaires, the interview and the treatment pose no obvious risks to your health. Some of the questions concern private topics such as sexuality and mental health that may be uncomfortable to answer. The treatment has no known serious negative side effects, but if you experience any, please discuss this with your therapist. We will also ask you in detail about any side effects, at the end of the study.
After sharing your thoughts and feelings with a professional therapist, you may feel relieved. Your sexual thoughts, feelings or behaviors regarding children may decrease thanks to the treatment.
The risk of privacy breaches is low. The platform used has several security systems built in, we do not collect any personal data, and we encourage you to use an anonymous email address that is only used for this study.
What happens to my data?
All data collected is self-reported and you will be completely anonymous. All data will be handled confidentially, stored so that unauthorized persons cannot access it, and all persons handling the data are subject to a duty of confidentiality. Data will be handled in accordance with the Karolinska Institute's archive rules for research documents, and saved for at least ten years after the research results have been reported. The results of the study will be presented in articles in scientific journals, but no information will be able to be linked to any individual.
Data may be shared with other countries/organizations to enable further research studies such as meta-analyses. All data shared is anonymous.
GDPR (The General Data Protection Regulation) is not applicable because you are anonymous. According to the Social Services Act, we are obliged to report to them if we know of any child who is at risk of being harmed. The social service then has the right to request all personal data we have about you.
How do I receive information about the results of the project?
If you are interested in taking part in the final research reports, you can contact the responsible researcher, see below. As your participation is anonymous, it is not possible for you to request your individual data.
Insurance and compensation
Because your participation is anonymous, there will be no patient insurance covering your participation and you will not be entitled to any financial compensation. Your participation is free of charge.
Participation is voluntary
Your participation is voluntary and you can choose to cancel your participation at any time. If you choose not to participate or wish to cancel your participation, you do not need to state why.
If you wish to cancel your participation, you notify your therapist via the platform.
Responsible for the project
The person responsible for the project is Christoffer Rahm, MD PhD, specialist in psychiatry, Karolinska Institutet, who can be reached at firstname.lastname@example.org or 070-001 14 57.
You may now start your registration to the study.
By checking "I consent" below you consent to the following statements: