Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219349
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2005-09-14
Brief Title:
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety DisorderGAD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder A Pilot Investigation
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DisorderGAD 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 andor 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
1 To disseminate and examine the effectiveness of a manualized individual cognitive-behavioral psychotherapy CBT for adults with Generalized Anxiety DisorderGAD 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 andor 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 escitalopramLexapro 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 Lexaprois 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 andor 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 andor 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
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 Lexaprois 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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None