Beat the Blues: Treating Depression in African American Elders
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|ClinicalTrials.gov Identifier: NCT00511680|
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : August 8, 2012
The specific primary aims of the study are to:
- 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.
- 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.
- 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 participant's 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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Stress Reduction Behavioral Activation Treatment||Behavioral: Behavioral Based In-Home Intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Treating Depression in African American Elders: A Community-Academic Partnership|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2012|
Experimental: Behavioral based In-home Intervention
This group will recieve up to 10 1-hour sessions over a 4 month period.
Behavioral: Behavioral Based In-Home Intervention
The 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research.
- Depression [ Time Frame: Baseline, t2, t3 ]
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): NCT00511680
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Laura N. Gitlin, Ph.D||Johns Hopkins University|