Clinical Trials Directory

Trials / Completed

CompletedNCT00765219

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
Phase
N/A
Study type
Interventional
Enrollment
222 (estimated)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCBT10-12 weekly sessions of CBT in person or over the telephone.
OTHERUsual CareTreatment as usual provided by participants' physician(s)

Timeline

Start date
2008-05-01
Primary completion
2013-12-01
Completion
2015-04-01
First posted
2008-10-02
Last updated
2015-07-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00765219. Inclusion in this directory is not an endorsement.