Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder 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 treatment (CBT) can be delivered effectively by providers of different expertise levels 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 in later life. Given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts. The treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (CBT) with an Anxiety Clinic Specialist (ACS) or Counselor or to Usual Care (UC). All participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. During the first 12 weeks, those assigned to CBT will also complete 10-12 weekly sessions, either in person or over the telephone. During the second 12 weeks, CBT patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. During the treatment phase, UC participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers. At 6 months, all participants will complete a telephone assessment. CBT patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. UC participants will be offered the option to receive brief CBT after completion of the 6 month telephone assessment. Those who choose to participate in CBT will complete telephone assessments at 9 and 12 months.

Official Title
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Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: CBT
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 and older Principal or Co-principal GAD diagnosis Patient at participating clinic Exclusion Criteria: Active suicidal intent Current psychosis or bipolar disorder Substance abuse within the past month Cognitive impairment according to a Mini Cog screener score of 3 or lower

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>CBT with ACS | Behavioral: CBT<br>* 10-12 weekly sessions of CBT in person or over the telephone.<br>* Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy;|
| Experimental: 2<br>CBT with Counselor | Behavioral: CBT<br>* 10-12 weekly sessions of CBT in person or over the telephone.<br>* Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy;|
| Active Comparator: 3<br>Usual Care | Other: Usual Care<br>* Treatment as usual provided by participants' physician(s)<br>* Other names: Treatment as Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | 18 months | 
| Sleep quality |  | 18 months | 
| Use of alcohol |  | 18 months | 
| Functional and health status |  | 18 months | 
| Quality of life |  | 18 months | 
| Pain |  | 18 months | 
| Satisfaction with CBT and general health care |  | 18 months | 
| Service utilization |  | 18 months | 
| Use of psychotropic medications |  | 18 months | 

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