Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511680
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-08-02
Brief Title:
Beat the Blues Treating Depression in African American Elders
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Treating Depression in African American Elders A Community-Academic Partnership
Status:
COMPLETED
Status Verified Date:
2012-08
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 specific primary aims of the study are to
1 Test the immediate effect of the intervention at 4-months on depression in urban African American older adults primary trial outcome between group comparison Hypothesis Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care
2 Test the maintenance effect of the intervention at 8-months on depression within group comparison Hypothesis Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months
3 Evaluate acceptability social validity of the intervention and extent of engagement in activities by study participants both intervention and wait-list control subjects
A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership We also propose three exploratory aims First we seek to evaluate the mechanisms of action or pathways by which treatment gains are obtained Gitlin et al 2000 Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention we plan to evaluate its mediational effect Second we seek to evaluate whether the intervention has a differential treatment effect based on a study participants gender age and living arrangement alone or with others Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others Third we seek to evaluate whether the intervention has short and long-term effects on quality of life functional difficulty and self-efficacy to manage day-to-day tasks Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time
1 Test the immediate effect of the intervention at 4-months on depression in urban African American older adults primary trial outcome between group comparison Hypothesis Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care
2 Test the maintenance effect of the intervention at 8-months on depression within group comparison Hypothesis Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months
3 Evaluate acceptability social validity of the intervention and extent of engagement in activities by study participants both intervention and wait-list control subjects
A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership We also propose three exploratory aims First we seek to evaluate the mechanisms of action or pathways by which treatment gains are obtained Gitlin et al 2000 Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention we plan to evaluate its mediational effect Second we seek to evaluate whether the intervention has a differential treatment effect based on a study participants gender age and living arrangement alone or with others Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others Third we seek to evaluate whether the intervention has short and long-term effects on quality of life functional difficulty and self-efficacy to manage day-to-day tasks Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time
Detailed Description:
None
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