1. Who is running this study?
The study is funded by the National Institutes of Health (NIH) and is located at Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School. The hospital is situated in the Longwood Medical Area of Boston, Massachusetts. Brigham and Women’s Hospital is a world-renowned center for health care, research and education.
Dr. Arthur Barsky, the Principal Investigator of the Health Study, is a distinguished expert on health-related anxiety and psychological treatments for bothersome physical symptoms. He is Professor of Psychiatry at Harvard Medical School, Director of Psychiatric Research at Brigham and Women’s Hospital in Boston, and has published widely on illness anxiety and hypochondriasis.
Click here to meet the Boston site’s faculty and staff
2. Why are you collecting my personal information?
We do not use personal information for commercial purposes or share it with people who are not a part of our research staff. We collect your personal information for several reasons. First, to properly conduct and oversee this research study. Second, to ensure that this study meets certain legal, institutional, and accreditation requirements. Third, to conduct public health activities. We also use this information for various treatment, payment, and healthcare operations.
3. What are you going to do with my personal information?
Personal identifying information (like your name, address, or telephone number) that is collected throughout this study will not be shared. Other information that is collected will be used only for research purposes and in a way that will not identify you. We do not share personal identifying information and any information that is used in publications will contain no such information.
4. Can I participate if I don’t want to take Fluoxetine (“Prozac”)?
Unfortunately, participants in this study must be randomly assigned (like a flip of a coin) to one of the four treatment conditions we offer. In fact, we don’t even control the condition you will be assigned to be in. If you are hesitant about taking Prozac (Fluoxetine) you can contact us (by phone: 617-732-5969 or e-mail: healthstudy@partners.org) where we can refer you to the Principal Investigator of the study who can discuss this with you.
It is important to understand that the side effects may be bothersome, but they are not harmful or dangerous to your health. We also minimize them by beginning treatment at a very low dose and increase only as tolerated.
5. What happens if I’m assigned to the placebo condition? Can I get a different treatment?
People assigned to the placebo condition will not know whether they have been taking fluoxetine (“Prozac”) or a placebo (an inactive “sugar pill”). In fact, we won’t even know which of these treatments you will receive until the treatment is over. But at that time, if you have been receiving placebo, you will be given the opportunity to take the active medication for an additional 3 months.
If it turns out that you were receiving the placebo, we offer you the opportunity to take the active treatment that you did not receive initially.
6. I’ve tried therapy before and it didn’t help me with my other problems, why will it help me now?
The therapy used in this study has been specially designed to treat people with heightened illness-related concerns, it has been shown to be clinically effective in our prior research, and is likely to be somewhat different from other forms of therapy you may have encountered. It is also worth noting that different forms of therapy seem to work for different people, and the therapy used in this study may only prove beneficial for some of the people receiving it. In fact, trying to understand who does and doesn’t benefit from this therapy is one of the things we are examining in this study.
7. How much money will I receive for participating in the study?
Study participants are compensated with $550 for six research interviews that are conducted throughout the study. These interviews take place during and after participation in the study. Participants are compensated for the initial on-site screening ($50), for interviews taking place before the first ($75), twelfth ($100), and twenty-fourth ($100) visits), for a phone interview 36 weeks after the beginning of the study ($25), and a final interview 48 weeks after beginning the treatment ($100). We do not compensate participants for taking part in the treatment sessions but we provide these at no charge to the participants or their insurance.
8. When do I receive my payment for participating in the study?
Participants will receive their payment about four weeks after completing each research interview. We realize this may be inconvenient for some people but we cannot compensate people faster for technical reasons.
9. I think my parent/sibling/child/significant other is a hypochondriac. Can you contact him/her about this study?
Unfortunately, we cannot contact people who have not contacted us. However, we will be happy to answer any questions you have and send you relevant information that you can share with others. Please contact us at 617-732-5969 or at healthstudy@partners.org.
10. What is Cognitive/Behavioral Therapy?
Cognitive/Behavioral Therapy is a form of psychological therapy (often referred to as CBT) that focuses on people’s emotions, thought processes, and behaviors and uses these to change negative thoughts and emotions. It is different from some forms of therapy because it focuses on current beliefs and behaviors (as opposed to events that have taken place earlier in a person’s life) and it is more structured and more educational than other forms of therapy. In our study, we are using Cognitive/Behavioral Therapy to teach people how to better manage bothersome symptoms and health-related worries. In a previous study, this Cognitive/Behavioral Therapy was significantly more effective than usual treatment in helping most people with this type of concerns.
