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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: CBT; Other: Usual Care

• Registration Number: NCT00765219
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2013-12
• Study Completion: 2015-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CBT	CBT with ACS
3	Usual Care	Usual Care
2	CBT	CBT with Counselor

Primary Outcome Measures

Name	Time	Method
Anxiety	18 months

Secondary Outcome Measures

Name	Time	Method
Use of alcohol	18 months
Functional and health status	18 months
Quality of life	18 months
Sleep quality	18 months
Satisfaction with CBT and general health care	18 months
Depression	18 months
Pain	18 months
Service utilization	18 months
Use of psychotropic medications	18 months

Trial Locations

Locations (1)

Houston Center for Quality of Care and Utilization Studies; 🇺🇸 Houston, Texas, United States