Clinical Trial: Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation

Brief 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 Summary:

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 escital
Sponsor: New York State Psychiatric Institute

Current Primary Outcome:

  • Change in Hamilton Anxiety Rating Scale Score [ Time Frame: week 14 to week 26 ]
    The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.
  • Clinical Global Impressions-Improvement Index [ Time Frame: week 26 ]
  • Clinical Global Impressions-Severity Index [ Time Frame: week 14 to week 26 ]
  • GAD Severity Scale [ Time Frame: week 14 to week 26 ]
  • Penn State Worry Questionnaire [ Time Frame: week 14 to week 26 ]
  • State-Trait Anxiety Inventory [ Time Frame: week 14 to week 26 ]
  • Change in Hamilton Anxiety Scale Score [ Time Frame: week 14 to week 26 ]


Original Primary Outcome:

  • Structured Clinical Interview for DSM-IV
  • Hamilton Anxiety Rating Scale
  • Clinical Global Impressions-Improvement Index
  • Clinical Global Impressions-Severity Index
  • GAD Severity Scale
  • Penn State Worry Questionnaire
  • State-Trait Anxiety Inventory


Current Secondary Outcome:

  • Hamilton Rating Scale for Depression [ Time Frame: week 14 to week 26 ]
  • Beck Depression Inventory-II [ Time Frame: week 14 to week 26 ]


Original Secondary Outcome:

  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory-II
  • Catastrophic Worry Questionnaire
  • Generalized Anxiety Disorder Questionnaire-IV
  • Inventory of Interpersonal Problems
  • Social Problem Solving Inventory - Revised


Information By: New York State Psychiatric Institute

Dates:
Date Received: September 14, 2005
Date Started: January 2005
Date Completion:
Last Updated: April 11, 2012
Last Verified: April 2012