Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204152
Status:
TERMINATED
Last Update Posted:
2013-09-05
First Post:
2005-09-13
Brief Title:
Treatment for Chronic Depression
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Treatment for Chronic Depression With Behavioral Interventions
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left U of C
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression including Behavioral Activation Jacobson et al 2001 and an integrated version of Behavioral Activation and Stress Innoculation Coping BASIC for short-term 16 weeks of individual psychotherapy for adults with chronic major depression The control condition is an individual workbook condition of Behavioral Activation These psychotherapies focus on behavior activation stress reduction and coping strategies to counter depressive symptoms
Detailed Description:
Early-onset unipolar major depression is linked with considerable morbidity and mortality Birmaher et al 1996 The goal of this project is to test the efficacy of Behavioral Activation BA Jacobson et al 2001 and an integrated version of Behavioral Activation BA Stress Inoculation Coping BASIC for the short-term psychotherapy of adults with chronic major depression onset before age 18 and a history of early life stress before age 18 Exposure to stress during the developmental years has been linked with early-onset depression Rao et al 1996 a propensity to generate stress during the life span Hammen et al 1998 and a greater psychological sensitivity to stress as an adult Post et al 1992 And while incidence of early life stress is high among depressed adults there are no behavioral treatments designed to address the unique needs of these individuals We aim to develop a new treatment for a specific group of depressed patients namely individuals who report early onset of depression and early life stress We include the critical elements of behavioral activation and stress reduction strategies to address the avoidance stress sensitivities and coping deficits often observed in this population
The specific aims are 1 to determine if the addition of stress reduction strategies packaged in BASIC enhance the effects of BA as indexed by the rate early remission 2 to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination as indexed by reduced rates of relapse by the 3-month follow-up and 3 to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA control condition using a randomized clinical trial design to distinguish between conditions We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse
The specific aims are 1 to determine if the addition of stress reduction strategies packaged in BASIC enhance the effects of BA as indexed by the rate early remission 2 to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination as indexed by reduced rates of relapse by the 3-month follow-up and 3 to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA control condition using a randomized clinical trial design to distinguish between conditions We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse
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