Using research to piece together the puzzle of depression, bipolar disorder, and related illnesses:
Frequently asked questions and answers about research participation
Participating in research is one of the most powerful ways to make a difference in improving mental health care, and there are many ways to get involved. We asked several researchers at the Depression Center to provide their perspectives on research participation based on their many years of experience developing studies and working with participants.
Why is research important?
Research is the only way that we can find new treatments and improve existing ones so they can work better for more people living with mental health conditions. It’s also how we learn about how illnesses develop so we can create new approaches to prevent them. None of the treatments we have today for depression, bipolar disorder, anxiety, and other conditions would exist without the knowledge gained from research and the people who participated in those studies.
What is mental health research?
You may hear a lot about “clinical trials,” which test how treatments work for people, but not all mental health research falls in this category. Some “observational” or “basic science studies” look at genetics or symptoms to learn more about the underlying causes of illness. And not all clinical studies are “drug trials.” Although some clinical trials test how well medications work, others examine the effectiveness of other types of treatment, like talk therapy or exercise.
Who can participate?
To make progress in mental health care, studies need participation from men, women, and children of all backgrounds and ages, and people living with certain medical conditions as well as people who are not (sometimes referred to as “healthy controls.”). Not all studies fit everyone, however. “When we design a research study, we put the criteria together in a specific way to answer specific questions, and you won’t qualify if you don’t meet those specific criteria,” explains Vicki Ellingrod, Pharm.D., BCPP, whose research examines the way in which genetic profiles may determine how people respond to medication. Criteria for a study may include age, gender, or the treatments you are using. “Other studies may possibly put you at unnecessary risk, so it may not be in your best interest to participate at that time,” she says. It’s important to note that even if one study isn’t a good fit for you, there may be others that are.
Study activities and safety
What will I be asked to do in a study?
It really depends on the study. Some studies involve being interviewed or completing a survey about your condition or other topics. Others might involve blood draws, brain imaging, or psychological tests. In a clinical trial, participants may receive a treatment to see how well it works for them – this could include medicine or talk therapy, or making behavior changes (e.g. with diet or exercise) that might affect mental health. All of these studies need participants, and you can choose a study with activities that are a good match for you.
What’s the time commitment?
“Research studies can last anywhere from minutes to decades,” says Patricia Deldin, Ph.D. Dr. Deldin directs U-M’s Mood and Schizophrenia Lab, and her research examines the biological aspects of cognition and emotion in mood disorders, among other things. Shorter studies might involve completing a questionnaire or giving a sample of saliva or blood, or require a few hours of observation or tests to examine how a person reacts to certain stimuli. Some of Dr. Deldin’s studies that examine connections between changes in sleep patterns and mood ask participants to spend several nights in the Depression Center Sleep Lab.
Richard Dopp, M.D., who researches the relationship between depression, sleep, and exercise among youth, notes that his treatment studies usually last 12 weeks or more. Studies that introduce new treatments such as medicine, talk therapy, or changes to diet or exercise, typically require at least a few months to determine how well the treatments are working.
“Sometimes we’re interested in following people over the course of their illness – or over their lifetime – to see how their illness has changed or whether treatment worked over a long-term period,” Dr. Deldin says. One such example is the Prechter Bipolar Longitudinal Study, in which researchers analyze genetic information and track participants’ health over a period of least 10 years.
How is safety protected?
Research conducted by a university or major medical institution must be reviewed and approved by a group of scientists and community members known as an Institutional Review Board, or “IRB.” The IRB must approve the research plan, or “protocol,” before any activities may begin, and it monitors the study for its duration. “The IRB makes sure potential risks will be managed properly and that potential benefits are appropriate given the possible risks,” explains Stephan Taylor, M.D., who, in addition to serving as vice chair of the IRB of the U-M Medical School, conducts research on a variety of psychiatric illnesses. IRBs scrutinize all parts of studies, including what participants will do during a study, who will be working on the study (and their qualifications), how the study will recruit participants, and how the study team will protect privacy and the information collected.
Informed consent is a process of ongoing communication between the research team and participants. It ensures that potential volunteers are informed of all critical information they need to make an informed decision about participating (such as procedures, risks, and benefits) and that they have the opportunity to ask any questions about the study or their participation. Signing an informed consent form (which contains important information about the study) says that you understand the information given to you and that you agree to participate, but you always have the choice to leave a study at any time, for any reason.
“The consent form is a mechanism for us to communicate what we are doing in the research, and to ask for voluntary participation, which means you can leave the study if you feel uncomfortable, at any point,” says Jon-Kar Zubieta, M.D., Ph.D., who uses imaging technologies to examine changes in the brain related to depression, substance abuse disorders, and stress. “This ensures that the safety of the participants is the most important part of the whole process.”
“You should have no hesitation to contact the people running the study if you have any questions related to the research, or if you have had something happen to you that you think might be part of the research,” says Dr. Ellingrod.
Research risks and benefits
What are the potential benefits to participants? What are the risks?
All studies have risks and benefits. These will vary from study to study, and they will also be different for different people. You should always make sure you understand the risks and benefits involved in a study so you can consider whether participating is right for you.
“For some studies, the potential risks may be very simple things like having to travel, or even becoming bored, while other studies involve procedures like neurosurgery that carry the risk of complications,” says Dr. Deldin. Some people may be willing to expose themselves to bigger risks if the possible benefits outweigh them, like undergoing a newer procedure that has the potential to improve treatment-resistant depression, for example. The important thing to remember is that the risks and benefits of any study, however large or small, have been carefully considered by the IRB that approved the study, and that research activities will be tracked throughout the course of the study to make participation as safe as possible.
For Julie Kaplow, Ph.D., ABPP, who researches grief, posttraumatic stress disorder, and stress response in young people, “the main concern from parents is that the questions we might be asking their children in our study, such as questions about their thoughts and feelings related to the death of a loved one, might be harmful to their child. What we’re finding is that actually the opposite is true – many kids actually welcome these questions, because it validates and normalizes their experience, and it also often opens up more doors of communication between parents and children, which is ultimately very helpful,” she says.
Many participants say the greatest benefit lies in being part of a team effort to search for answers that can improve lives. Participants have also said that being in a study helped them better understand their own illness. In some cases, participating in a research study may also provide access to new treatments before they are widely available, additional medical care at a reduced cost or no cost, and compensation for contributing one’s time and effort.
Are participants compensated?
“We do compensate our research participants for a number of our studies. We know that they’re busy, and that they have families and jobs and responsibilities. And so we value that, and we try to compensate them appropriately based on the time they spend with us, and what may be asked of them in participating,” says Daphne C. Watkins, Ph.D., whose research focuses on depression in men. Before you agree to participate in a study, the research team will inform you of any compensation offered, which may include money, gift cards, or other incentives. “Certainly, this is not a way to make a living,” says Depression Center Executive Director John Greden, M.D. “Compensation for participants’ time, their effort, or their willingness to do things that may be uncomfortable – having blood drawn, or spending a night in the hospital, for example – is really just a fair approach to saying ‘you have helped the world of medicine and healthcare, and you deserve something in return.’”
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“The response from our participants has always been extremely positive. Why? Because in the process of participating in research, our patients learn more about their illness, and they also see the progress in the field as far as the efforts being made to understand the illness. Both investigators and participants learn a great deal from each other and are very much rewarded by the experience,” says Dr. Zubieta.
Srijan Sen, M.D., Ph.D, who conducts genetic research with the aim of refining screening methods and developing more personalized treatments for individuals with depression, says that participants in his studies are true partners who provide invaluable insights into the research process. “Our participants are truly excited about taking part in the research, and they make incredibly constructive suggestions about things that we should be looking at that are important in their particular depression story that we haven’t thought about before,” he says. “The feedback has been enormously constructive in helping us create better studies and improve our confidentiality safeguards.”
Sheila Marcus, M.D., whose research involves working with at-risk mothers and babies to prevent depression, says, “I think for most people, participating is about giving back. If this illness has affected me or has affected those that I love, how can I use this illness to help others understand how to better treat it, how to prevent it, how to identify it, how to reach out and help other children and adults with the illness?”
“In general, children thoroughly enjoy their participation in studies,” Dr. Marcus says. “I think many kids by nature are very giving and altruistic, and they enjoy the idea that they can give back and help other kids out. Kids also often like the financial benefit that they receive for participating in studies -- our teenagers in particular find that having some additional pocket change is fun for them. And they also seem to have a lot of fun with some of our studies where they might be involved with imaging or computers or other technical things.”
Dr. Dopp says of his young participants, “Some have told us that they appreciate the time and interest that the research faculty spends in getting to know them and what their challenges are. Some enjoy the process of participating in research and learning aspects of research methodology. Others are happy to contribute to science and the greater good. And some are just hoping to feel better.”
He notes that while some teen participants are initially motivated by monetary incentives, their interest typically evolves into something deeper. “Some like the idea of trying something different and being involved in some cutting-edge work. Others are getting benefits from research in terms of what they learn about their depression, and learning life strategies that they can use – for over the course of the research study and beyond.”
To learn more...
Visit umhealthresearch.org to explore participation opportunities.