Graduate

Center for Multidisciplinary Studies of Chronic Fatigue Syndrome Pathogenesis

Principal Investigator: Nancy Klimas, M.D.
Co- Principal Investigator: MaryAnn Fletcher, Ph.D.
Investigator: Michael H. Antoni, Ph.D.

The proposed four-year study examines the effects of a cognitive behavioral stress management (CBSM) intervention (including progressive muscle relaxation training and cognitive restructuring) on physical health status and illness burden in 120 patients diagnosed with Chronic Fatigue Syndrome (CFS).  The study tests the efficacy of a conceptual model which holds that the interaction of psychological factors (distress and depression associated with either CFS-related symptoms or other stressful life events) and immunologic dysfunction (elevations in cytokines such as tumor necrosis factor [TNFI-A and 0 and the macrophage activation marker, neopterin) contribute to:

1. the exacerbation of physical symptoms associated with CFS (e.g., fatigue, joint pain, fever) and subsequent increases in illness burden (operationalized as disruptions in daily activities due to fatigue and related physical symptoms), and
2. further dysfunction in the immune system (e.g., impaired lymphocyte proliferative responses to phytobemagglutinin [PHAI and natural killer c6ll cytotoxicity [NKCCI).

The proposed revised study tests this model experimentally by first evaluating the effects of a 10 week group CBSM intervention upon the health outcome variables: physical health status (CFS symptoms) and CFS-related illness burden.  Secondly, this study examines the role of two sets of hypothesized mediator variables:

1. reductions in psychological distress and depression levels, and
2. immune system modulation (less impaired NKCC and PHA responsivity, lowered TNF-A and P peptides and receptors in serum and MRNA in circulating lymphocytes, reduced neopterin levels, reduced numbers of lymphocy, subsets expressing activation markers).

To bring about these effects the intervention is hypothesize,ito directly modulate a set of psychosocial intervention targets that we hypothesize will influence the mediator variables. These intervention targets include increased optimism, reductions in distorted cognitive appraisals, greater use of active and engaging coping strategies, and increased perceptions of social support provisions. This is a randomized Weriment with a 10-week CBSM (plus standard care CBSM/SC) condition vs. an Education plus standard care (ED/SC) control condition. At the end of the 10-week CBSM intervention, the CBSM/SC group will continue on a standard of care regimen at the co-P.I.'s clinic and will be monitored on a monthly basis, for their adherence to the techniques learned in the CBSM intervention and for intercurrent medical treatment. At the end of the 10-week ED/SC period the control group will be subsequently monitored as they continue on their standard of care. We will also follow subjects at 3, 6 and 12 months post-CBSM to assess treatment carryover and to correlate prospectively pre-post CBSM changes in intervention targets with mediator and health outcome variables measured at these follow-up points.