An RCT of CBT-Telephone for Late-Life GAD

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DESCRIPTION (provided by applicant): Research on anxiety disorders in older adults is of growing importance due to its high prevalence. Anxiety is associated with significant morbidity and mortality, highlighting the urgency to develop effective treatments. In this R01 resubmission from a New Investigator, we propose a carefully designed clinical trial to test a cognitive behavioral treatment for late-life GAD, delivered by telephone and workbook to community-dwelling rural elders. The proposal builds upon the PI's successful K Award findings, in which she demonstrated the feasibility of recruiting diverse older adults, satisfaction with the treatment, very low attrition rates (8.3%), and preliminary evidence of the efficacy of the intervention in reducing symptoms of anxiety and worry. Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered using a telephone and workbook format, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults = 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy delivered by telephone. The 2 primary treatment outcomes are anxiety symptoms as assessed by the HAM-A, and worry symptoms as assessed by the PSWQ- A. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.