This application is a revised application for a competing renewal of an ongoing clinical trial of cognitive behavior therapy (CBT) in older adults with generalized anxiety disorder (GAD) (R01-MH53932). Data from the original funding period support the efficacy of CBT for this cohort. The next step in this program of research is to test the outcome of similar treatment procedures in primary care settings where older adults already are receiving medical care. The proposed project is a randomized hybrid efficacy-effectiveness study designed to examine the utility of CBT, relative to Usual Care (UC), for GAD among medical patients age 60 years or older. As the initial test of CBT outcomes for older anxious adults in primary care, the study represents a first step beyond the classic clinical trial. In the proposed study, 150 medical patients, age 60 and older, whose symptoms meet DSM-IV criteria for GAD (APA, 1994) will be recruited through internal medicine, family practice, and geriatric clinics within two large managed care practices in the Houston metropolitan area, The Kelsev-Sevbold Clinic and MacGregor Medical Association. Patients will be assigned randomly to CBT or UC. CST will be conducted on an individual basis, preferably at the clinic site, although arrangements can be made to provide service in the patient's home. Treatment will occur for at least 8 sessions, with additional sessions scheduled for patients with immediate crises or those who need additional time to learn coping skills. Booster sessions will be offered at all follow-up appointments. Patients assigned to UC will continue to receive regular treatment from health care providers. Given a projected attrition rate of 30%, 106 patients (53 per group) are expected to be available for post-treatment and follow-up analyses. Assessments will be conducted at pre- and post-treatment, as well as at 3-, 6-, 9-, and 12-month follow-up. The effects of CBT at post-treatment will address clinical, functional, and satisfaction outcomes. Clinical outcomes will assess target symptoms (worry, anxiety) and coexistent symptoms (depression, sleep, alcohol use). Functional outcomes will assess functional status and quality of life. Satisfaction outcomes will assess patient satisfaction with CBT and general health care. The long-term effects of treatment will be assessed over a one-year period and will target clinical, functional, and satisfaction outcomes, as well as the impact of treatment on service utilization. Service utilization will encompass frequency of visits for physical and emotional problems, frequency of referrals for mental health care, type and frequency of medical tests and procedures, andmedication use. In addition to evaluation of outcomes, the study also will allow preliminary examination of treatment response predictors at both post-treatment and over follow-up.
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