Beat the Blues: Treating Depression in African American Elders
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Depression Stress Reduction Behavioral Activation Treatment |
Behavioral: Behavioral Based In-Home Intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) |
| Official Title: | Treating Depression in African American Elders: A Community-Academic Partnership |
- Depression [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]
| Enrollment: | 192 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Laura N. Gitlin, Ph.D | Johns Hopkins University |
More Information
No publications provided by Thomas Jefferson University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laura N. Gitlin, Director, Center for Innovative Care in Aging, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00511680 History of Changes |
| Other Study ID Numbers: | 1 Ro1 MH079814 |
| Study First Received: | August 2, 2007 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013