Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, Geriatric
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.
Interventions
BEHAVIORALCognitive Behavior Therapy
8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
BEHAVIORALTelephone check-in
Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
Sponsors
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
Michael E. DeBakey VA Medical Center
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety | Baseline and 3, 6, 9, 12 and 15 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life inventory (QOLI) | Baseline and 3, 6, 9, 12 and 15 months |
| Satisfaction with CBT and general health care | Baseline and 3, 6, 9, 12 and 15 months |
| Service utilization | Baseline and 3, 6, 9, 12 and 15 months |
| Functional and health status | Baseline and 3, 6, 9, 12 and 15 months |
| Sleep quality | Baseline and 3, 6, 9, 12 and 15 months |
| Use of alcohol and other substances | Baseline and 3, 6, 9, 12 and 15 months |
| Depression | Baseline and 3, 6, 9, 12 and 15 months |
Countries
United States
Outcome results
None listed