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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00765219
Enrollment
222
Registered
2008-10-02
Start date
2008-05-31
Completion date
2015-04-30
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder, Geriatric

Brief summary

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

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.

Interventions

BEHAVIORALCBT

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

OTHERUsual Care

Treatment as usual provided by participants' physician(s)

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Anxiety18 months

Secondary

MeasureTime frame
Depression18 months
Sleep quality18 months
Use of alcohol18 months
Functional and health status18 months
Use of psychotropic medications18 months
Pain18 months
Satisfaction with CBT and general health care18 months
Service utilization18 months
Quality of life18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026