Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and
societal costs in terms of quality of life, social and work functioning, health care use, and
lost productivity. Although single therapy approaches such as medication, graduated exercise,
and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the
majority of FMS continue to report significant levels of pain and pain-related disability.
Testing the efficacy of using combination therapies such and CBT with medication has
considerable potential to maximize treatment response. Also, exploring the biological and
psychological mechanisms underlying combination treatment may pave the way for developing new
treatments for FMS sufferers.
We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate
medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment
arm in a study that has both time and budgetary constraints, 3) the complexity in
understanding the mechanism of actions of 3 different modes of intervention in one clinical
trial, and 4) the desire to explore mechanisms in this program of research, in particular the
potential effects of a biological intervention (drug) on what is traditionally considered a
psychological outcome (pain-related attributions and cognition) and the potential effects of
a psychological intervention (CBT) on what is traditionally considered a physiological
outcome (pain sensitivity).
Phase:
Phase 4
Details
Lead Sponsor:
Indiana University
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)