|Principal Investigator (PI): Mark A. Lumley,
Project Coordinator: Nancy Lockhart, RN
| Principal Investigator (PI):
David A.Williams, Ph.D.
Recruiting Coordinator: Emilia Mondragon
Researchers at Wayne State University and the University of Michigan are seeking adults who have fibromyalgia for a randomized clinical trial of different methods to manage pain and stress. This study is funded by the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS).
This clinical trial is investigating three different interventions to improve pain, other symptoms, and functioning experienced by people with fibromyalgia, and to determine which people are most likely to benefit from each intervention.
These interventions focus on one of three topics: Stress and Emotions, Thoughts and Behaviors, or Brain and Body. This study does not require you to change your medication or usual medical care.
How the study works:
Screening Session: You will be asked to participate in one screening session to determine your eligibility for this study. This session will involve an interview about your medical, social history, and psychiatric history, a tender point exam, and completing some questionnaires about your health, beliefs, and personality. This screening visit lasts about 2 hours.
Interventions: Each participant will be randomly assigned to one of three interventions and must be willing to participate in the one to which they are assigned. All three interventions have the same format: one 90-minute session per week for 8 weeks, which are held in groups of about six participants.
These are the three interventions:
Stress and Emotions: This intervention seeks to reduce stress and fibromyalgia symptoms by helping you become aware of your emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
Thoughts and Behaviors: This intervention seeks to help you function better and improve your symptoms by teaching you various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
Brain and Body: This intervention seeks to help you improve your health by educating you about fibromyalgia so that you can better understand and more effectively communicate about your health. It will teach you the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
Evaluation Sessions: You will have three evaluation sessions, each of which last 2 to 3 hours. One evaluation will be before the intervention, and two will be after it, over the next 6 months. These evaluations will assess your pain, health, functioning, and heart rate. Also, you will wear a watch-like device for 2 weeks at home that records your movements or activity. Finally, one year after the intervention we will contact you and ask you to fill out questionnaires.
The study is being conducted by both Wayne State University and the University of Michigan, and we have multiple sites for the study throughout the Metro Detroit area. We will work with patients to schedule at their preferred location, and when possible, we will offer day and evening sessions.
Study Costs and Compensation:
If you are interested in learning more about the study or seeing if you are eligible to participate, please contact one of the locations below that is most convenient for you:
Wayne State University
University of Michigan Medical Center