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A Randomized Clinical Trial

Melinda A. Stanley, PhD; Nancy L. Wilson, MS, MSW; Diane M. Novy, PhD; Howard M. Rhoades, PhD; Paula D. Wagener, BA; Anthony J. Greisinger, PhD; Jeffrey A. Cully, PhD; Mark E. Kunik, MD, MPH

JAMA. 2009;301(14):1460-1467.

Context  Cognitive behavior therapy (CBT) can be effective for late-life generalized anxiety disorder (GAD), but only pilot studies have been conducted in primary care, where older adults most often seek treatment.

Objective  To examine effects of CBT relative to enhanced usual care (EUC) in older adults with GAD in primary care.

Design, Setting, and Participants  Randomized clinical trial recruiting 134 older adults (mean age, 66.9 years) from March 2004 to August 2006 in 2 primary care settings. Treatment was provided for 3 months; assessments were conducted at baseline, posttreatment (3 months), and over 12 months of follow-up, with assessments at 6, 9, 12, and 15 months.

Intervention  Cognitive behavior therapy (n = 70) conducted in the primary care clinics. Treatment included education and awareness, motivational interviewing, relaxation training, cognitive therapy, exposure, problem-solving skills training, and behavioral sleep management. Patients assigned to receive EUC (n = 64) received biweekly telephone calls to ensure patient safety and provide minimal support.

Main Outcome Measures  Primary outcomes included worry severity (Penn State Worry Questionnaire) and GAD severity (GAD Severity Scale). Secondary outcomes included anxiety ratings (Hamilton Anxiety Rating Scale, Beck Anxiety Inventory), coexistent depressive symptoms (Beck Depression Inventory II), and physical/mental health quality of life (12-Item Short Form Health Survey).

Results  Cognitive behavior therapy compared with EUC significantly improved worry severity (45.6 [95% confidence interval {CI}, 43.4-47.8] vs 54.4 [95% CI, 51.4-57.3], respectively; P < .001), depressive symptoms (10.2 [95% CI, 8.5-11.9] vs 12.8 [95% CI, 10.5-15.1], P = .02), and general mental health (49.6 [95% CI, 47.4-51.8] vs 45.3 [95% CI, 42.6-47.9], P = .008). There was no difference in GAD severity in patients receiving CBT vs those receiving EUC (8.6 [95% CI, 7.7-9.5] vs 9.9 [95% CI, 8.7-11.1], P = .19). In intention-to-treat analyses, response rates defined according to worry severity were higher following CBT compared with EUC at 3 months (40.0% [28/70] vs 21.9% [14/64], P = .02).

Conclusions  Compared with EUC, CBT resulted in greater improvement in worry severity, depressive symptoms, and general mental health for older patients with GAD in primary care. However, a measure of GAD severity did not indicate greater improvement with CBT.

Trial Registration  clinicaltrials.gov Identifier: NCT00308724

Author Affiliations: Houston Center for Quality of Care & Utilization Studies (Drs Stanley, Cully, and Kunik and Mss Wilson and Wagener); Baylor College of Medicine (Drs Stanley, Cully, and Kunik and Ms Wilson); The University of Texas M. D. Anderson Cancer Center (Dr Novy); The University of Texas Health Science Center at Houston (Dr Rhoades); Kelsey Research Foundation (Dr Greisinger); Michael E. DeBakey Veterans Affairs Medical Center (Drs Cully and Kunik); and VA South Central Mental Illness, Research, Education and Clinical Center (Drs Cully and Kunik), Houston, Texas.

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