Beat the Blues: Treating Depression in African American Elders

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511680
• Other study ID #: 1 Ro1 MH079814
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2007
• Last updated: August 7, 2012
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Behavioral Activation Treatment
• Depression
• Depressive Disorder
• Stress Reduction

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression		Baseline, t2, t3	No