Ignite Creation Date:
2024-05-05 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00635999
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2008-03-12
Brief Title:
A Comparison Between Cognitive Behavioral and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder
Sponsor:
Michelle G Newman
Organization:
Penn State University
Study Overview
Official Title:
Desensitization and Cognitive Therapy in General Anxiety
Status:
COMPLETED
Status Verified Date:
2018-01
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:
This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder
Detailed Description:
Generalized anxiety disorder GAD is a common psychiatric disorder that affects nearly 68 million adults in the United States GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult GAD is often accompanied by physical symptoms as well including muscle aches nausea sweating exhaustion irritability frequent urination and shaking People with GAD are also at a higher risk for other disorders including depression and substance abuse making early treatment of GAD important Forms of psychotherapy that concentrate on stress management relaxation techniques and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD This study will evaluate the effectiveness of three adaptive coping treatments relaxation and self-control desensitization cognitive behavioral therapy CBT and a combination of the two in lessening anxiety in adults with GAD
Participation in this study will last about 28 months All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history self-report questionnaires and a physiological evaluation After the first interview participants will be asked to rate their level of anxiety four times a day in a diary They will continue with these daily diary entries through the completion of treatment Once participants complete the first 2 weeks worth of daily ratings participants will be assigned randomly to receive treatment with relaxation and self-control desensitization CBT or a combination of the two treatments All participants will receive 14 weekly treatment sessions lasting between 15 and 2 hours each During CBT sessions participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety Between sessions all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries
Upon completion of treatment participants will repeat the initial assessments Follow-up visits will occur at Months 6 12 and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 weeks worth of daily diary entries before each visit
Participation in this study will last about 28 months All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history self-report questionnaires and a physiological evaluation After the first interview participants will be asked to rate their level of anxiety four times a day in a diary They will continue with these daily diary entries through the completion of treatment Once participants complete the first 2 weeks worth of daily ratings participants will be assigned randomly to receive treatment with relaxation and self-control desensitization CBT or a combination of the two treatments All participants will receive 14 weekly treatment sessions lasting between 15 and 2 hours each During CBT sessions participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety Between sessions all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries
Upon completion of treatment participants will repeat the initial assessments Follow-up visits will occur at Months 6 12 and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 weeks worth of daily diary entries before each visit
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