NCT00511680

Brief Summary

The specific primary aims of the study are to:

  1. 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. 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. 3.Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Sep 2008

Typical duration for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

August 2, 2007

Last Update Submit

August 7, 2012

Conditions

DepressionStress ReductionBehavioral Activation Treatment

Outcome Measures

Primary Outcomes (1)

  • Depression

    Baseline, t2, t3

Study Arms (1)

Behavioral based In-home Intervention

EXPERIMENTAL

This group will recieve up to 10 1-hour sessions over a 4 month period.

Behavioral: Behavioral Based In-Home Intervention

Interventions

Behavioral Based In-Home InterventionBEHAVIORAL

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.

Behavioral based In-home Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

  • Gitlin LN, Harris LF, McCoy MC, Hess E, Hauck WW. Delivery Characteristics, Acceptability, and Depression Outcomes of a Home-based Depression Intervention for Older African Americans: The Get Busy Get Better Program. Gerontologist. 2016 Oct;56(5):956-65. doi: 10.1093/geront/gnv117. Epub 2015 Nov 25.

    PMID: 26608333DERIVED

  • Gitlin LN, Szanton SL, Huang J, Roth DL. Factors mediating the effects of a depression intervention on functional disability in older African Americans. J Am Geriatr Soc. 2014 Dec;62(12):2280-7. doi: 10.1111/jgs.13156.

    PMID: 25516024DERIVED

  • Gitlin LN, Roth DL, Huang J. Mediators of the impact of a home-based intervention (beat the blues) on depressive symptoms among older African Americans. Psychol Aging. 2014 Sep;29(3):601-11. doi: 10.1037/a0036784.

    PMID: 25244479DERIVED

  • Gitlin LN, Harris LF, McCoy MC, Chernett NL, Pizzi LT, Jutkowitz E, Hess E, Hauck WW. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):243-52. doi: 10.7326/0003-4819-159-4-201308200-00005.

    PMID: 24026257DERIVED

  • Jutkowitz E, Pizzi L, Hess E, Suh DC, Gitlin LN. Comparison of three societally derived health-state classification values among older African Americans with depressive symptoms. Qual Life Res. 2013 Aug;22(6):1491-8. doi: 10.1007/s11136-012-0263-y. Epub 2012 Sep 13.

    PMID: 22972437DERIVED

  • Gitlin LN, Harris LF, McCoy M, Chernett NL, Jutkowitz E, Pizzi LT; Beat the Blues Team. A community-integrated home based depression intervention for older African Americans: [corrected] description of the Beat the Blues randomized trial and intervention costs. BMC Geriatr. 2012 Feb 10;12:4. doi: 10.1186/1471-2318-12-4.

    PMID: 22325065DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Laura N. Gitlin, Ph.D

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Innovative Care in Aging

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

US(1)