Bipolar II in Primary Care

Study Terms and Conditions

You are being asked to take part in a research study. Before you decide to participate in this study, it is important that you understand why the research is being done and what it will involve. Please read the following information carefully. Please ask the researcher if there is anything that is not clear or if you need more information.

The process you are asked to participate in is part of a study focused on identifying hypomania in depressed patients presenting in primary care. The researcher is also interested in your thoughts and opinions on utilizing the Hypomania Checklist 33 External Audit (HCL-33-EA) for this purpose. Please ask the researcher if there is anything that is not clear or if you need more information. Cheri Creighton, 714/925-4106, cheri@bipolardisordersinprimarycare.com

STUDY PROCEDURES

Your participation will consist of either an anonymous online survey and/or a brief anonymous interview lasting approximately 5-10 minutes. All interviews will be conducted via phone or over Zoom, a HIPAA-compliant communications platform that allows users in different locations to connect with video, audio, phone, and chat.

You will be asked questions about your experience with undiagnosed bipolar II and your thoughts on the HCL-33-EA questionnaire as a tool that could help better identify hypomania. Once interviews are complete, the recordings will be transcribed, and data organized and coded by themes for reporting.

RISKS

The probability of harm to participants is highly unlikely but could include exposure of identifying information. To avoid such instances, all online surveys and interviews will be anonymous. For interviews, identifying information will be encrypted including practitioner names, name of practice, and location through Microsoft Forms, which is HIPAA compliant and meets the General Data Protection Regulation (GDPR) for properly handling personal data. Participants will be referred to by fictitious names or aliases in all reports to be reviewed or made public.

You may decline to answer any or all questions and you may terminate your involvement at any time if you choose.

BENEFITS

The researcher expresses gratitude for participants who give their time to answer questions. We hope that the information obtained from this study may be used to determine if further testing of the screening tool should be conducted in primary care. We hope to improve the diagnosis of patients with undiagnosed bipolar disorders presenting in primary care for the treatment of depression.

CONFIDENTIALITY

Your responses to this online questionnaire or interview questions will be anonymous. For those who choose to participate in the interview process, every effort will be made by the researcher to preserve your confidentiality including the following:

  • Recorded interviews will be stored on Zoom’s cloud storage, which will be encrypted, and password protected.
  • Written transcription of the interviews will be stored using Microsoft Forms on a USB hard drive that will remain in one locked location.
  • Interviews, notes, and records will be kept for 3 years, as required by federal regulations.
  • After this time, cloud recordings and any paper or electronic documents will be permanently deleted. All paper documents will be shredded, and electronic files will be permanently deleted from cloud storage and the USB hard drive.

Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents. These incidents include, but may not be limited to, incidents of abuse and suicide risk.

VOLUNTARY PARTICIPATION

Your participation in this study is voluntary. It is up to you to decide whether or not to take part in this study. If you decide to take part in the interview process of this study, you will be asked to sign a consent form. After you sign the consent form, you are still free to withdraw at any time and without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed.

CONSENT

I have read and understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. By checking the box below, I voluntarily agree to take part in this study.

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