CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 192 enrolled
Drug / intervention
Behavioral Based In-Home Interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00511680
NCT00511680Phase 3Completed

Treating Depression in African American Elders: A Community-Academic Partnership

Thomas Jefferson University·interventional·Posted Aug 6, 2007·Updated Aug 8, 2012

In Brief

A Phase 3 clinical trial evaluating Behavioral Based In-Home Intervention for Depression and 2 related conditions. Completed, enrolled 192 participants across 1 site.

Detailed 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 may have the added value of enhancing function and perceived efficacy for this group over time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2007
Enrollment StartSep 1, 2008
Primary CompletionJun 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.9 years ago

Interventions

Behavioral Based In-Home Interventionbehavioral

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.