We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Beat the Blues: Treating Depression in African American Elders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511680
First Posted: August 6, 2007
Last Update Posted: August 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laura N. Gitlin, Johns Hopkins University
  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 (Investigator)
Official Title: Treating Depression in African American Elders: A Community-Academic Partnership

Resource links provided by NLM:


Further study details as provided by Laura N. Gitlin, Johns Hopkins University:

Primary Outcome Measures:
  • Depression [ Time Frame: Baseline, t2, t3 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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: 1R01MH079814 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2007
First Posted: August 6, 2007
Last Update Posted: August 8, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders