This request for an Independent Scientist Award (KO2) fosters the candidate's research proficiency in personality disorders and treatment development within the context of three randomized clinical trials (RCTs) on the efficacy of cognitive therapy (CT) in reducing the likelihood of mood disorders in high risk or refractory outpatients. Project 1 (an ongoing R01) compares continuation phase CT (C-CT) to evaluation only (control) in reducing the risk of relapse during the first eight months following response to acute phase CT in outpatients with recurrent major depressive disorder (MDD). Approximately 156 male and female outpatients, aged 18-65, have entered 20 sessions of acute phase CT. Approximately 84 responders were randomized to either 8 months of: (a) 10 C-CT sessions, or (b) 10 evaluation only (control sessions); subjects are followed for an additional 16 months CT free. Relapse/recurrence (DSM IF MDD) is assessed by a blind evaluator using the LIFE at 4, 8, 12, and 24 months post-acute phase CT and at suspected relapse/recurrence, or exit. Project 2 is a proposed, multi-site collaboration with University of Pittsburgh (Western Psychiatric Institute and Clinic; WPIC). This blinded, controlled RCT will evaluate the efficacy of and indications for eight months of C-CT, pharmacotherapy (the standard of care) (FLX: fluoxetine), and pill placebo (PBO: the control) in outpatients with recurrent MDD who are at higher risk for relapse/recurrence. """"""""Higher risk"""""""" is a score >6 on the Hamilton Rating Scale for Depression (HRS-D) during the last six weeks of acute phase CT, while """"""""lower risk"""""""" is defined as a score of 6 or less. The primary hypotheses is that higher risk patients who receive either C-CT or FLX have a longer time until relapse than higher risk patients who receive acute phase CT only plus PBO. The lower risk patients will be followed for 24 months without CT and are predicted to have a 20% relapse/recurrence rate in the first 8 months after acute phase CT. Project 3 is a proposed, multi-site collaboration with WPIC comparing the differential efficacy of a trial of: (a) FLX and (b) FLX plus CT in out- patients with recurrent MDD who were refractory to 20 sessions of acute phase CT. Blind evaluation of outcome will aid in testing the prediction that combination therapy is more efficacious for refractory depression than FLX alone. The KO2 focuses the candidate on (a) identifying the residual symptoms and social impairment remaining after CT and (b) designing treatment sequences to restore full functioning. These RCTs have great public health significance because they will help identify (a) when CT reduces the risk of relapse-recurrence for patients suffering from recurrent MDD, an illness with high morbidity and mortality, and (b) if refractory MDD is best treated with combination therapy.
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