Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care

Baylor College of Medicine

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Other: Usual Care; Behavioral: CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00765219

R01MH053932-10A1 (U.S. NIH Grant/Contract)

H23798

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 222 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 3 patient groups

1

Experimental group

Description:

CBT with ACS

Treatment:

Behavioral: CBT

2

Experimental group

Description:

CBT with Counselor

Treatment:

Behavioral: CBT

3

Active Comparator group

Description:

Usual Care

Treatment:

Other: Usual Care