Research Study Summary for Potential Subjects
You are being invited to participate in a research study. Your participation is voluntary and you should only participate if you completely understand what the study requires and what the risks of participation are. You should ask the study team any questions you have related to participating before agreeing to join the study. If you have any questions about your rights as a human research participant at any time before, during or after participation, please contact the Institutional Review Board (IRB) at (215) 898-2614 for assistance.
The research study is being conducted to understand mental health providers' beliefs about using exposure-based therapy to treat OCD in pregnancy, their experiences using exposure-based methods in this population, and any reservations about using this method. This research will further our understanding of how pregnant patients with OCD are being treated in practice and inform further efficacy research or treatment guidelines.
If you agree to join the study, you will be asked to complete the following research procedures:
- Participate in a one-time, brief online survey through REDCap (Research Electronic Data Capture) that includes:
- a demographics form (age, gender, sex, race, ethnicity, education, profession, licensure, years in practice, direct service hours, and specialty).
- a survey on your beliefs about using exposure-based therapy for OCD in pregnancy.
- After completing the survey, participants will also complete an established questionnaire assessing therapists' perceptions of exposure therapy (Therapist Beliefs about Exposure Scale; Deacon et al., 2013)
Your participation will last for about 10-15 minutes total.
Please note that there are other factors to consider before agreeing to participate such as additional procedures, use of your personal information, costs, and other possible risks not discussed here. You are free to decline or stop participation at any time during or after the initial consenting process.
Why am I being asked to volunteer?
You are being asked to take part in a research study. Your participation is voluntary which means you can choose whether or not to participate. If you decide to participate or not to participate there will be no loss of benefits to which you are otherwise entitled. Before you make a decision you will need to know the purpose of the study, the possible risks and benefits of being in the study and what you will have to do if you decide to participate as outlined in this consent form. You do not have to make a decision now; you can review the consent document on your own and share it with friends and family.
If you do not understand what you are reading, do not sign it. Please ask the researcher to explain anything you do not understand, including any language contained in this form. If you decide to participate, you will click the consent to participate box at the end of the form and an electronic copy will be available for download. Keep this form, in it you will find contact information and answers to questions about the study.
This is not a form of treatment or therapy. It is not supposed to detect a disease or find something wrong.
What is the purpose of the study?
The purpose of the study is to learn more about mental health providers' beliefs about using exposure-based therapy to treat OCD in pregnancy, their experience using exposure-based methods in this population, and any reservations about using this method. We hope to understand how pregnant patients with OCD are currently treated in practice and inform further efficacy research or treatment guidelines as needed.
Why was I asked to participate in this study?
You are being asked to join this study because you are a mental health clinician that may treat patients in the perinatal period, patients with anxiety and OCD-related concerns, or both. This study aims to survey mental health clinicians (psychologists, counselors, social workers, psychiatrists and others) who have had (or would like) the opportunity to treat pregnant patients with OCD.
How long will I be in the study?
The study will take place over a period of 1 year. However, your participation will take place on a day and time of your choosing and the survey session will last about 10-15 minutes.
Where will the study take place?
You will be asked to provide survey answers remotely. This study does not require that you be seen in person to participate.
What will I be asked to do?
First, you will be asked to read and provide consent for the study. Then, you will be asked to fill out a confidential electronic survey through RedCap which should take about 10-15 minutes to complete. The survey will include questions about your demographic characteristics, professional experience, and regarding your experience, beliefs, and practices with pregnant patients with OCD.
What are the risks?
Risks of participating in the research study include possible psychological discomfort while providing responses about experiences and reservations about specific therapies used in your practice. Another study risk is related to your loss of confidentiality or private information. Several steps will be taken to protect your privacy as described in the section below labeled "How will my personal information be protected?" We will take several precautions to protect your privacy, but complete privacy can never be guaranteed.
How will I benefit from the study?
There is no direct benefit to you from participating in the study. However, your participation could help us understand the safety, tolerability, and efficacy of an evidence-based psychotherapy in a vulnerable and understudied population, which can benefit you and patients with OCD indirectly. In the future, this may help other people (including patients and clinicians) by informing clinical practice guidelines in the future.
What other choices do I have?
Your alternative to being in the study is to not participate in the study. Alternatively, you could choose to participate in other research through the University of Pennsylvania or elsewhere. Declining to participate in this study does not influence your ability to participate in future studies or workshops.
What happens if I do not choose to join the research study?
You may choose to join the study or you may choose not to join the study. Your participation is voluntary. There is no penalty if you choose not to join the research study. You will lose no benefits or advantages that are now coming to you, or would come to you in the future.
When is the study over? Can I leave the study before it ends?
The study is expected to end after all participants have completed the survey and all the information has been collected. The study may be stopped without your consent for the following reasons:
- The Primary Investigator (PI) feels it is best for your safety and/or health-you will be informed of the reasons why.
- You have not followed the study instructions
- The PI, the sponsor or the Office of Regulatory Affairs at the University of Pennsylvania can stop the study anytime
You have the right to drop out of the research study at any time during your participation. There is no penalty or loss of benefits to which you are otherwise entitled if you decide to do so.
If you no longer wish to be in the research study, please contact Dr. Erica Weitz at erica.weitz@pennmedicine.upenn.edu and ask to be withdrawn from the study.
How will my personal information be protected during the study?
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. The Institutional Review Board (IRB) at the University of Pennsylvania will have access to your records.
Your confidentiality will be maintained by using a unique subject identification number on all records instead of your name. Survey answers will be coded using unique identifiers and stored within the RedCap system which is housed on University of Pennsylvania's password protected servers. RedCap will not be able to access your information, we will only be using their survey services to collect answers to survey questions. De-identified electronic data containing personal health information will be protected with a password and the information will be encrypted (scrambled using a special code).
What may happen to my information collected on this study?
Future Use of Data and/or Specimens
Your information will be de-identified. De-identified means that all identifiers have been removed. It is possible that de-identified data could be shared with other researchers at Penn or other institutions for further analysis. However, it would not be possible for further researchers to identify you as no identifiable information would be shared. This can be done without again seeking your consent in the future, as permitted by law. The future use of your information only applies to the information collected on this study.
Will I have to pay for anything?
There are no financial costs to participate in the study.
Will I be paid for being in this study?
After participation in this study, you will be entered into a raffle and may win a $50 gift certificate. The odds for winning the gift certificate are between 2-5% depending on the number of survey respondents.
Who can I call with questions, complaints or if I'm concerned about my rights as a research subject?
If you have questions, concerns or complaints regarding your participation in this research study or if you have any questions about your rights as a research subject, you should speak with the Principal Investigator listed on page one of this form. If a member of the research team cannot be reached or you want to talk to someone other than those working on the study, you may contact the Office of Regulatory Affairs with any question, concerns or complaints at the University of Pennsylvania by calling (215) 898-2614.
By electronically signing, you are agreeing to take part in this research study. If you have any questions or there is something you do not understand, please ask. You will receive a copy of this consent document.