NCT02860741

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

7.6 years

First QC Date

August 5, 2016

Last Update Submit

January 16, 2024

Conditions

Depressive Symptoms

Keywords

Sub-Clinical Depression

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately upon completion of 8 week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period

Behavioral: REJOICE

Control

OTHER

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

Interventions

REJOICEBEHAVIORAL

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
ControlOTHER

Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.

Also known as: Usual Care
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Second Baptist Church of England

England, Arkansas, 72046, United States

Location

King Solomon

Helena, Arkansas, 72342, United States

Location

Greater Christ Temple

Little Rock, Arkansas, 72204, United States

Location

Evangelist Temple COGIC

Little Rock, Arkansas, 72209, United States

Location

Related Publications (1)

  • 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.

    PMID: 29170075DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Tiffany F Haynes, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

  • Karen Yeary, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

  • Camille Hart, MPH

    cnhart@uams.edu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 9, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)