Clinical trial NCT00308724: Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
Official title: Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Geriatric
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
name: The University of Texas Health Science Center, Houston
name: Kelsey Research Foundation
name: Kelsey-Seybold Clinic
name: Michael E. DeBakey VA Medical Center
First posted: 2006-03-30
Enrollment: 148
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
Secondary outcomes:
measure: Functional and health status
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Quality of life inventory (QOLI)
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Satisfaction with CBT and general health care
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Service utilization
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Depression
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Sleep quality
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
measure: Use of alcohol and other substances
timeFrame: Baseline and 3, 6, 9, 12 and 15 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Center for Quality of Care and Utilization Studies
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Melinda A. Stanley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available.
citation: Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available.
citation: 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.
citation: Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12.
citation: 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. doi: 10.1001/jama.2009.458.