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Beat the Blues: Treating Depression in African American Elders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura N. Gitlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00511680
First received: August 2, 2007
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


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

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511680

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014