Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
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|ClinicalTrials.gov Identifier: NCT00219349|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 9, 2012
Last Update Posted : December 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Behavioral: Cognitive Behavioral Therapy Drug: escitalopram||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy
14 weekly sessions of individualized CBT
10-20 mg per day for 12 weeks
Other Name: lexapro
- 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.
- Change in Clinical Global Impressions-Severity Index [ Time Frame: week 14 to week 26 ]7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.
- Change in Generalized Anxiety Disorder Severity Scale [ Time Frame: week 14 to week 26 ]measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.
- Change in Penn State Worry Questionnaire [ Time Frame: week 14 to week 26 ]total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)
- Change in State-Trait Anxiety Inventory, State Subscale [ Time Frame: week 14 to week 26 ]only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)
- Clinical Global Impressions-Improvement Index [ Time Frame: week 26 ]This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)
- Change in Hamilton Rating Scale for Depression [ Time Frame: week 14 to week 26 ]24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)
- Change in Beck Depression Inventory-II [ Time Frame: week 14 to week 26 ]total score ranges from 0 (not depressed) to 63 (most severe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219349
|United States, New York|
|Anxiety Disorders Clinic, New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Franklin R. Schneier, M.D.||New York State Psychiatric Institute|
|Principal Investigator:||Kenneth D Belzer, Ph.D.||New York State Psychiatric Institute|