Generalized Anxiety Disorder Clinical Trial
Official title:
Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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