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Reducing Depressive Symptoms Among Rural African Americans (REJOICE)

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ClinicalTrials.gov Identifier: NCT02860741
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
Rural African Americans are disproportionately impacted by social stressors that place them at risk for experiencing elevated depressive symptoms. This project will test the effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use within rural African American churches. Further, this project will gather data on strategies necessary to promote the successful implementation of this intervention within rural African American churches.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: REJOICE Other: Control Not Applicable

Detailed Description:

Rural African Americans are disproportionately exposed to numerous stressors such as poverty, racism, and discrimination that place them at risk for experiencing elevated levels of depressive symptoms. Elevated levels of depressive symptoms can lead to a host of negative outcomes including both the development of and poor management of chronic illnesses (i.e. hypertension, diabetes, etc.), poor social functioning, poor occupational functioning, and development of clinical depression. Though effective treatments for decreasing depressive symptoms exist, rural African Americans often fail to receive adequate and timely care.

African American churches have been identified as potential venues for providing depression education and treatment for rural African Americans. Within the African American rural community, churches represent a key portal through which a large proportion (as much as 85%) of the African American community can be reached. Churches have been used to address physical health outcomes in those communities but few have focused primarily on addressing mental health outcomes.

Through the NIMHD funded project entitled, "Faith Academic Initiatives to Transform Health (FAITH) in the Delta", our partnership, consisting of faith community leaders and UAMS researchers, culturally adapted an evidence-based behavioral activation intervention for use with rural African American churches. This 8-session behavioral activation therapy was adapted to include faith-based themes, Scripture, and other aspects of the rural African American faith culture (e.g. bible studies, use of lay leaders to deliver the intervention). In addition to assessing the effectiveness of our intervention, ascertaining ways to implement this intervention with proper fidelity to maintain clinical outcomes is also critically important to increase the efficiency of translating research into practice. Work towards disseminating evidence-based depression interventions to "real world" settings is particularly salient in addressing depression disparities, whereby rural African Americans bear a disproportionate burden. Thus, this application proposes a Hybrid-2 pragmatic-effectiveness implementation trial that seeks to test the effectiveness of the culturally adapted evidence-based intervention and gather preliminary data on the strategies necessary to support successful implementation of this intervention in rural African American churches.

Specifically, this study aims to: 1) Refine a culturally appropriate, evidence-based depression intervention (REJOICE) based on results from our NIMHD-funded pilot study, 2) Determine whether REJOICE is superior to a usual-care control group at post treatment and a 3-month follow-up, 3) Collect pilot data regarding "real world" implementation strategies (i.e. face to face training and coaching calls) on the uptake and maintenance of REJOICE in rural African American churches.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Reducing Depressive Symptoms Among Rural African Americans
Study Start Date : May 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period
Behavioral: REJOICE
Small groups led by lay leaders undergo an 8-session faith-based behavioral activation protocol that provides individuals with education about: identifying depressive symptoms, identifying pleasurable activities, scheduling pleasurable activities, and identifying and addressing avoidant behaviors that act as barriers to completing pleasurable activities

Control
Churches in the control arm will receive an educational materials about both identifying depressive symptoms and managing depressive symptoms. This is consistent with self-management interventions commonly utilized for individuals experiencing subclinical levels of depressive symptoms.
Other: Control
Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.
Other Name: Usual Care




Primary Outcome Measures :
  1. Depressive Symptoms - Beck Depression Inventory (BDI-II) [ Time Frame: Immediately upon completion of 8 week intervention ]
    The primary outcome of interest is evaluating differences in BDI-II scores among those individuals in the REJOICE cohort compared to those randomized into the control group during the T1 phase.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • Aged 18 and older
  • Mild to moderate levels of depressive symptoms (scores of 11-20 on the Beck Depression Inventory-II (BDI-II)
  • Associated with a participating church through membership or participation in a church activity
  • Free of medical problems that might contraindicate participation in a BA intervention (i.e. active intoxication (scores of 3 or more on the AUDIT-C), cognitive decline (score of 4 or more on the Brief Cognitive Screener51).

Exclusion Criteria:

  • Individuals who are experiencing severe levels of depressive symptoms (scores of 21 or higher on BDI-II)

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): NCT02860741


Contacts
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Contact: Ellen M Hutchins, MPH 501-526-6676 emhutchins@uams.edu
Contact: Tiffany F Haynes, PhD 501-526-6613 TFHaynes@uams.edu

Locations
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United States, Arkansas
Gethsemane Missionary Baptist Church Recruiting
Brinkley, Arkansas, United States, 72021
Contact: Sylvia Halliburton         
McGhee Chapel Not yet recruiting
Bryant, Arkansas, United States, 72202
Precious Grove MBC Not yet recruiting
Crumrod, Arkansas, United States, 72328
Contact: Betty Carter         
Hunt Memorial Not yet recruiting
Dumas, Arkansas, United States, 71639
Contact: Linda Rogers         
True Harvest Recruiting
Dumas, Arkansas, United States, 71639
Contact: Victor Witherspoon         
Fellowship Community Church Not yet recruiting
Forrest City, Arkansas, United States, 72335
Contact: Beverly Newborn         
King Solomon Active, not recruiting
Helena, Arkansas, United States, 72342
First Missionary Baptist Not yet recruiting
Humphrey, Arkansas, United States, 72073
Contact: Margarett Owens         
Greater Christ Temple Active, not recruiting
Little Rock, Arkansas, United States, 72204
Evangelist Temple COGIC Recruiting
Little Rock, Arkansas, United States, 72209
Contact: Jeanette Ester         
Kingdom Connections Recruiting
Marianna, Arkansas, United States, 72360
Contact: Keith Ross         
Mt. Calvary Not yet recruiting
Marianna, Arkansas, United States, 72360
Contact: LaKeisha Smith         
Second Chance Ministries Active, not recruiting
McGehee, Arkansas, United States, 71654
Family Time Baptist Church and Ministries Recruiting
Pine Bluff, Arkansas, United States, 71603
Contact: Linda Kemp-Martin         
Mt. Carmel Baptist Church Recruiting
Pine Bluff, Arkansas, United States, 71603
Contact: Angela Anderson         
Pine Bluff Study Group Recruiting
Pine Bluff, Arkansas, United States, 71603
Contact: Kurt Muhammad         
Greater First Baptist Not yet recruiting
West Helena, Arkansas, United States, 72390
Contact: Camille Germany         
New Faith Baptist Church Not yet recruiting
West Helena, Arkansas, United States, 72390
Contact: Izah Broadus         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Tiffany F Haynes, PhD Assistant Professor
Principal Investigator: Karen Yeary, PhD Associate Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02860741     History of Changes
Other Study ID Numbers: 205181
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Arkansas:
Sub-Clinical Depression
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms