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NCT00511680 · ClinicalTrials.gov registry record · Phase 3
Beat the Blues: Treating Depression in African American Elders
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
NCT00511680 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 192 participants.
The verdict
NCT00511680, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
Study 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 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
Interventions
- BEHAVIORAL Behavioral Based In-Home Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00511680
The ClinicalTrials.gov registry entry for NCT00511680 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Behavioral Based In-Home Intervention is the first listed.
NCT00511680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00511680 about?
NCT00511680 is a clinical study titled "Beat the Blues: Treating Depression in African American Elders". 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 symptom...
What is the current status of trial NCT00511680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2008-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00511680?
The interventions under investigation include: Behavioral Based In-Home Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00511680?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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