Generalized Anxiety Disorder Clinical Trial
Official title:
Worry Exposure for Generalized Anxiety Disorder
The purpose of this study is to examine the efficacy of a worry exposure intervention, a form of cognitive behavioral therapy (CBT), in comparison to a waitlist condition for the treatment of Generalized Anxiety Disorder. There will be a total of 60 subjects enrolled at the University of Texas at Austin. Patients will be randomized (like a flip of a coin) to either 12-sessions of WE therapy or a 12-week waitlist before being offered entry into therapy.
This application proposes a randomized controlled trial, which aims to examine the efficacy
of a worry exposure (WE) intervention for the treatment of generalized anxiety disorder
(GAD). This protocol is based on a GAD treatment manual first tested in Germany. It has been
translated into English, but this version has not yet been tested.
A growing body of research calls for the development of novel interventions for individuals
with GAD. GAD is a chronic and debilitating condition with high rates of recurrence, with a
lifetime prevalence of 5.7%. Although efficacious psychological interventions exist, many are
either not receiving these interventions or remain highly symptomatic following the
termination of these interventions. More specifically, cognitive behavioral therapy (CBT) is
the only empirically supported treatment for GAD. However, many patients relapse or continue
to experience significant symptoms after treatment. Up to 57% of patients do not meet
criteria for high endstate functioning after CBT. Together, these findings call for the
development of better interventions that are efficacious and easy to disseminate.
The core symptom of GAD is persistent and uncontrollable worry, which allows the individual a
way to cognitively avoid perceived threats and emotionally dangerous situations. One study
examined the efficacy of WE alone, applied relaxation (AR) alone, and a WL control group,
finding that WE was an effective treatment for GAD, concluding that WE should be developed
further. Given other areas of avoidance for patients with GAD, the authors recommended adding
in vivo exposure in future trials.
The present application proposes to test WE with the addition of in vivo exposure in the
United States as an effective treatment for GAD. The present study involves the randomization
of 60 adults with GAD to either (1) 12-sessions of WE therapy or (2) a 12-week waitlist (WL),
before entering into therapy. The authors hypothesize that participants in the WE
intervention will evidence greater reductions in anxiety symptom severity and measures of
quality of life relative to individuals randomized to the WL.
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