Beat the Blues: Treating Depression in African American Elders

Phase 3

Completed

• Conditions: Behavioral Activation Treatment; Depression; Stress Reduction
• Interventions: Behavioral: Behavioral Based In-Home Intervention

• Registration Number: NCT00511680
• Lead Sponsor: Thomas Jefferson University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Study Start: 2008-09
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• African American
• ≥55 years of age
• English speaking
• Cognitively intact (MMSE >24)
• Depressed as measured by a score ≥5 on the PHQ-9
• Must have a telephone
• Planning to live in the area for 8 months

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Exclusion Criteria

• Not African American
• <55 years of age
• Does not speak English
• MMSE<24
• Not depressed as measures by a score of <5 on the PHQ-9
• Does not have a telephone
• Does not plan to live in the area for 8 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral based In-home Intervention	Behavioral Based In-Home Intervention	This group will recieve up to 10 1-hour sessions over a 4 month period.

Primary Outcome Measures

Name	Time	Method
Depression	Baseline, t2, t3

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States