Reducing Depressive Symptoms Among Rural African Americans (REJOICE)
Primary Purpose
Depressive Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REJOICE
Control
Sponsored by
About this trial
This is an interventional health services research trial for Depressive Symptoms focused on measuring Sub-Clinical Depression
Eligibility Criteria
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)
Sites / Locations
- Second Baptist Church of EnglandRecruiting
- King Solomon
- Greater Christ Temple
- Evangelist Temple COGIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period
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.
Outcomes
Primary Outcome Measures
Depressive Symptoms - Beck Depression Inventory (BDI-II)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02860741
Brief Title
Reducing Depressive Symptoms Among Rural African Americans
Acronym
REJOICE
Official Title
Reducing Depressive Symptoms Among Rural African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Sub-Clinical Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REJOICE
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Usual Care
Intervention Description
Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.
Primary Outcome Measure Information:
Title
Depressive Symptoms - Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
Immediately upon completion of 8 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Hart, MPH
Phone
501-526-6076
Email
cnhart@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany F Haynes, PhD
Phone
501-526-6613
Email
TFHaynes@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany F Haynes, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Yeary, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Camille Hart, MPH
Organizational Affiliation
cnhart@uams.edu
Official's Role
Study Director
Facility Information:
Facility Name
Second Baptist Church of England
City
England
State/Province
Arkansas
ZIP/Postal Code
72046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darrell Montgomery
Facility Name
King Solomon
City
Helena
State/Province
Arkansas
ZIP/Postal Code
72342
Country
United States
Individual Site Status
Completed
Facility Name
Greater Christ Temple
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Evangelist Temple COGIC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29170075
Citation
Haynes T, Turner J, Smith J, Curran G, Bryant-Moore K, Ounpraseuth ST, Kramer T, Harris K, Hutchins E, Yeary KHK. Reducing depressive symptoms through behavioral activation in churches: A Hybrid-2 randomized effectiveness-implementation design. Contemp Clin Trials. 2018 Jan;64:22-29. doi: 10.1016/j.cct.2017.11.010. Epub 2017 Nov 21.
Results Reference
derived
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Reducing Depressive Symptoms Among Rural African Americans
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