At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Primary DSM-IV-TR diagnosis of Generalized Anxiety Disorder with no significant comorbid anxiety disorder (excluding PTSD, OCD, prominent panic disorder)
- ✓Penn State Worry Questionnaire score ≥55
- ✓Clinical Global Impression (CGI) severity score ≥4 (Moderately Ill)
- ✕Major Depressive Disorder diagnosis within 60 days prior to screening
- ✕Lifetime history of Schizophrenia, Major Depressive Disorder with psychotic or catatonic features, Bipolar I Disorder, or Organic Mental Disease
- ✕DSM-IV substance abuse or dependence in past 6 months (except nicotine or caffeine)
- ✕Active suicidal or homicidal ideation or serious suicide risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation
In Brief
A Phase 4 clinical trial evaluating Cognitive Behavioral Therapy and escitalopram for Generalized Anxiety Disorder. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
14 weekly sessions of individualized CBT
10-20 mg per day for 12 weeks