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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy
* Behavioral: Telephone check-in


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive Behavior Therapy | Behavioral: Cognitive Behavior Therapy<br>* 8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period<br>* Other names: CBT;|
| Active Comparator: 2<br>Usual Care | Behavioral: Telephone check-in<br>* Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety |  | Baseline and 3, 6, 9, 12 and 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and health status |  | Baseline and 3, 6, 9, 12 and 15 months | 
| Quality of life |  | 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 | 
| Depression |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, Geriatric