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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

CBT with ACS

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

10-12 weekly sessions of CBT in person or over the telephone.

2

CBT with Counselor

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

10-12 weekly sessions of CBT in person or over the telephone.

3

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Treatment as usual provided by participants' physician(s)

Interventions

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CBT

10-12 weekly sessions of CBT in person or over the telephone.

Intervention Type BEHAVIORAL

Usual Care

Treatment as usual provided by participants' physician(s)

Intervention Type OTHER

Other Intervention Names

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Cognitive Behavior Treatment, Cognitive Behavior Therapy Treatment as Usual

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No