Clinical trial NCT00511680: Beat the Blues: Treating Depression in African American Elders
Official title: Treating Depression in African American Elders: A Community-Academic Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Stress Reduction
Behavioral Activation Treatment
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2007-08-06
Enrollment: 192
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility 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

Primary outcomes:
measure: Depression
timeFrame: Baseline, t2, t3
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Laura N. Gitlin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.