The purpose of this application is twofold: 1) To provide a systematic plan for career development of the Candidate as a clinical researcher; and 2) to present a preliminary study application based on a sound research plan. The career development plan involves: a) taking graduate courses in advanced statistics and research methods, behavioral assessment, and ethical issues; and b) supervision by two mentors of the conduct of research by the Candidate.
The Specific Aims of the preliminary study are to: 1) compare in vivo and traditional retrospective outcome measures in patients with chronic fatigue syndrome (CFS) in order to assess the ecological validity of traditional measures in both naturalistic outcome (NO) and clinical outcome (CO) studies; 2) test the hypothesis, via secondary data analysis in the CO study, that a clinically meaningful classification of CFS patients into high and low functioning subgroups can be made on the dimension of physical functioning and validated with its relationship to role functioning, CFS symptom severity, and psychiatric symptomatology; and 3) test the hypothesis, via secondary data analysis in the CO study, that graded activity with cognitive therapy is more effective for low function participants and that cognitive-behavioral coping skills treatment is more effective for the high function subgroup. The NO and CO studies involve cohorts of 100 and 120 patients, respectively. Data collection will include 21 (NO study) or seven (CO study) consecutive daily in vivo assessments of physical activity (actigraphy), energy, fatigue, and affect. In vivo assessments will take place at baseline and at a 24 month follow-up in the NO study, and at baseline, treatment termination, and three, six, and 12 month follow-up intervals in the CO study. The findings of this study will have important implications for clinical management of this debilitating illness.
