Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The goals of this pilot study are as follows:

      1) To disseminate and examine the effectiveness of a manualized, individual,
      cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD),
      2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in
      participants who do not fully respond to CBT, and 3) to examine individual and clinical
      predictors of non-response to CBT and predictors of response to augmentation antidepressant
      therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT
      alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up
      period. This study will serve as a pilot investigation in preparation for a larger federally
      funded study using this treatment approach. We hypothesize that CBT will result in remission
      (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement)
      in approximately 40-50% of participants. Further, we hypothesize that augmentation
      antidepressant therapy in participants who do not fully respond to CBT will result in further
      clinically significant improvement.
    

Detailed description: 
      This pilot investigation will examine the effectiveness of augmenting cognitive behavioral
      therapy (CBT) with antidepressant pharmacotherapy (escitalopram[Lexapro]) in adults with
      generalized anxiety disorder (GAD) who do not fully respond to a temporally primary trial of
      CBT. A secondary aim of this study is to assess the maintenance of treatment gains made by
      patients in response to CBT, and to CBT with antidepressant augmentation therapy, over a
      two-year follow-up period.

      CBT is an empirically supported psychotherapy that has been found to be effective in treating
      GAD in approximately 50 percent of patients enrolled in controlled clinical trials. However,
      a substantial proportion (nearly half) of individuals with GAD do not achieve full remission
      or clinically significant improvement at the cessation of CBT. Escitalopram (Lexapro)is a
      selective serotonin reuptake inhibitor (SSRI) antidepressant, which has been shown to be
      effective in treating GAD in several large-scale controlled clinical trials. The Food and
      Drug Administration has approved ecitalopram for the treatment of GAD.

      The proposed research plan encompasses the conduct of an open clinical trial (No randomized
      placebo control) of 14 sessions of manualized individual CBT for persons meeting DSM-IV-TR
      diagnostic criteria for GAD. This study will use a treatment manual developed by Dr. Thomas
      Borkovec and colleagues at the Pennsylvania State University. Participants who meet high
      endstate functioning criteria and/or achieve remission following CBT will be evaluated
      periodically during a twenty-four month follow-up phase. Participants who do not meet high
      endstate functioning criteria and/or achieve remission following completion of CBT will be
      offered entry into a twelve-week, open-label, flexible-dose trial of escitalopram therapy.
      Participants receiving escitalopram therapy will be evaluated periodically during a
      twenty-four month follow-up phase, as well. It is anticipated that patients who do not fully
      respond to CBT will show a significant increment in improvement in GAD symptoms, over and
      above their CBT posttreatment level, following pharmacotherapy with escitalopram.

      At present, no studies with GAD populations have examined the additive or sequenced effects
      of psychosocial therapy and SSRI antidepressant pharmacotherapy. The proposed research is a
      first step in this direction and may provide evidence supporting the use of combined
      treatment modalities in CBT partial and non-responders.
    

Intervention name(s): Cognitive Behavioral Therapy; escitalopram
Intervention type(s): Behavioral; Drug
Intervention description(s): 14 weekly sessions of individualized CBT; 10-20 mg per day for 12 weeks
Other intervention name(s): lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety Disorders; Anxiety Neuroses; Behavior Therapy, Cognitive; Escitalopram