Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care

• Anxiety
• Depression
• Sleep Quality
• Use of alcohol and other substances

• Functional and health status [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Satisfaction with CBT and general health care [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Service utilization [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Depression [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Sleep quality [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
• Use of alcohol and other substances [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]

• Functional and health status
• Quality of life
• Satisfaction with CBT and general health care
• Service utilization

The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.

Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.

The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.

• Behavioral: Cognitive Behavior Therapy
  8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
  Other Name: CBT
• Behavioral: Telephone check-in
  Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition

• Experimental: 1
  Cognitive Behavior Therapy
  Intervention: Behavioral: Cognitive Behavior Therapy
• Active Comparator: 2
  Usual Care
  Intervention: Behavioral: Telephone check-in

• Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. Review. No abstract available.
• Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. No abstract available.
• Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.
• Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7.

Inclusion Criteria:

• Clinical diagnosis of Generalized Anxiety Disorder

Exclusion Criteria:

• Active suicidal intent
• Current psychosis
• Current bipolar disorder
• Substance abuse within past month
• Cognitive impairment

• National Institute of Mental Health (NIMH)
• National Institutes of Health (NIH)
• The University of Texas Health Science Center, Houston
• Kelsey Research Foundation
• Kelsey-Seybold Clinic
• VA Medical Center, Houston