This Mentored Patient-Oriented Research Career Development Award (K23) application is to request support for Dr. Gaudiano's development as an independent research scientist with expertise in combined psychosocial and pharmacological treatments for severe mood disorders. The initial goal will be to develop and evaluate an adjunctive intervention for treating psychotic depression. This research area is significant because currently there are no well-validated psychosocial treatments developed and tested for this high-risk population. The proposed project builds on Dr. Gaudiano's prior experience developing treatments for individuals with psychotic-spectrum disorders, but provides additional needed training in crucial areas. Dr. Gaudiano's training goals are to: 1) understand the phenomenology and treatment of psychotic depression by designing a novel psychosocial intervention;2) gain experience in the clinical and research issues related to the use of pharmacotherapy to inform a larger-scale study as part of a subsequent R01 submission;3) develop expertise in the design, execution, and statistical analysis of combined treatment trials;4) increase knowledge of ethical and multicultural issues in clinical and research work with severely mentally ill patient populations;and 5) expand grant writing and manuscript preparation skills. These goals will be achieved through: 1) resources available at Brown Medical School/Butler Hospital;2) high quality mentorship provided by Drs. Ivan Miller and Lawrence Price, and other consultant mentors;3) completion of formal coursework, seminars, and supervised clinical experiences;and 4) implementation of the proposed research program. As part of this K23 award, Dr. Gaudiano will complete a 5-year research plan focused on developing and evaluating a novel psychosocial intervention for psychotic depression, called Acceptance-Based Depression and Psychosis Treatment (ADAPT).
The aims of the research project are to: 1) develop a comprehensive treatment manual for ADAPT by conducting an initial open trial (n = 12);2) conduct a randomized controlled pilot study comparing routine hospital care and semi-structured outpatient pharmacotherapy with or without the addition of ADAPT for patients initially hospitalized with psychotic depression (n = 60);3) develop a therapist training program;4) develop therapist adherence and competence rating scales;and 5) adapt and specify a semi-structured pharmacotherapy protocol for use in a subsequent larger-scale clinical trial.
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