This is the second revision of a proposal, in response to the NIMH program announcement (PAR-03- 078) """"""""From Intervention Development to Services: Exploratory Research Grant (R34), focuses on the """"""""Development and Pilot Testing of New or Adapted Interventions"""""""" in a grossly underserved population, the elderly. Generalized anxiety disorder (GAD) is a common and increasingly prevalent psychiatric illness in the elderly. The resulting severe disability is comparable to but independent of the frequently comorbid depression. However, effective treatments for late-life GAD are lacking and pharmacotherapy dominates despite lack of evidence for its efficacy or acceptability. Because of the many advantages of psychosocial treatments over pharmacotherapy in this vulnerable population, recent studies have begun to examine the benefits of cognitive-behavior therapy (CBT) in the elderly. Unfortunately, response and remission rates to CBT seem generally lower in elderly patients compared to younger adults and high dropout rates further reduce overall response. The principal aim of this proposal is to collect pilot data on a multi-modal intervention for late-life GAD, involving augmentation of CBT with pharmacotherapy, incorporating a sequential procedure that allows for flexibility and patient choice;after four weeks of initial CBT, tailored to the specific needs of the elderly, patients will have the option to add pharmacotherapy or to continue with CBT alone for an additional 8 weeks. The unique features of this approach, reflecting the available literature and our own experience, should maximize patient acceptance and potential benefits. Given the wide range of rating instruments and the proven quality assurance procedures proposed, we hope to generate the information needed to plan a controlled, large-scale study in the future.
