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Reducing Depressive Symptoms Among Rural African Americans (REJOICE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02860741
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : July 1, 2020
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 2021
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

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.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • African American
  • Aged 18 and older
  • 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 identifier (NCT number): NCT02860741

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Contact: Ellen M Hutchins, MPH 501-526-6676
Contact: Tiffany F Haynes, PhD 501-526-6613

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United States, Arkansas
King Solomon Completed
Helena, Arkansas, United States, 72342
Greater Christ Temple Active, not recruiting
Little Rock, Arkansas, United States, 72204
Evangelist Temple COGIC Active, not recruiting
Little Rock, Arkansas, United States, 72209
McGehee Chapel Recruiting
McGehee, Arkansas, United States
Sponsors and Collaborators
University of Arkansas
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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 Identifier (NCT Number):
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Responsible Party: University of Arkansas Identifier: NCT02860741    
Other Study ID Numbers: 205181
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
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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Behavioral Symptoms