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Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities

Primary Purpose

Depression, Awareness, Self-management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oh Happy Day Class - Still I Rise
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • African American male or female
  • Age 25 and older
  • Residence in the state of Wisconsin
  • With or without depression

Exclusion Criteria:

  • Self-report of a psychotic disorder such as

    • schizophrenia
    • bipolar disorder
  • Cognitive disorder such as dementia
  • Presently experiencing suicidal ideations.

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oh Happy Day Class - Still I Rise

Arm Description

The Oh Happy Day Class-Still I Rise (OHDC-SIR) is a one-time, 4-hour class focused on awareness of depression and healthy self-management strategies ( a workbook is created with the class content). The class is offered in non clinical setting, but will be delivered in a classroom setting at the University. The class will be taught by the PI Dr. Ward, who is an associate professor and licensed psychologist, and Dr. Ward's research program manager, Lucretia Sullivan-Wade.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9 (PhQ-9)
Patient Health Questionnaire (PHQ-9 is a depression measure. PHQ-9 is a self-administered (5 minutes completion time) depression scale, which scores each of the 9 DSM-IV (Diagnostic and Statistical Manual-IV) criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores are summed, and scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2019
Last Updated
November 30, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
Urban League of Greater Madison, African American Council of Churches Madison, Second Baptist Church, YWCA of Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03940157
Brief Title
Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities
Official Title
Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Urban League of Greater Madison, African American Council of Churches Madison, Second Baptist Church, YWCA of Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Specific Aims/Study Objectives: 1. Evaluate acceptability and implementation of the "Oh Happy Day: Still I Rise Class," which comprise a one-time 4-hour class in which participants will learn about depression with the goal of increasing knowledge of depression and self-management of depression with use of a guided class and self-help workbook. Measures of acceptability will include class attendance, completion of workbook activities and satisfaction. Measures of implementation will include satisfaction, class enrollment, fidelity in delivery of class content, and cost analysis. 2) Evaluate participants' knowledge of depression pre-and immediate post-class, and 3-months post class. Measure: depression quiz. The investigators hypothesize participants will show increased knowledge of depression pre -and post-class. 3) Examine effectiveness of the Oh Happy Day Class- Still I Rise (OHDC-SIR) in prevention of depression and 3- months' post- class. Measure, Patient Health Questionnaire - ( PHQ-9) 4) Examine effectiveness of OHDC-SIR in reducing symptoms of depression 3- months' post- class. Measure, PHQ-9. The investigators hypothesize the OHDC-SIR will result in reduction in depressive symptoms 3- months' post-class.
Detailed Description
Major Depressive Disorder (MDD) is a major public health concern and is quickly approaching the status of a global public health crisis. According to the World Health Organization, by 2020 MDD will be the leading cause of disability globally. In the US an estimated 9.0% of adults report symptoms for current MDD (i.e., during the preceding 2 weeks). It is well documented that women (4.0%) are significantly more likely to report and be diagnosed with MDD compared to men (2.7%) NIMH, 20017). In addition, health disparities research examining MDD show African Americans evidence higher prevalence of depression (4.0%) compared to Whites (3.1%) and African Americans report more chronic MDD and associated disability than do Whites (56.5% vs. 38.6%; Williams et al., 2007). Despite being burdened by MDD, African Americans evidences low seeking of professional help. However, they highly rely on religious coping. This, it is important to work in partnership with African American clergy and African Americans in community based research to create programs that are more aligned with their cultural and religious beliefs. Investigators propose using a one-group (OHDC-SIR) non-randomized observational trial and a sample of 100 African American men and women participants (age 25 and older) with measures at baseline, immediately at the end of the class, and 3- months' post-class. The total duration of the study is 4 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Awareness, Self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be exposed to the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oh Happy Day Class - Still I Rise
Arm Type
Experimental
Arm Description
The Oh Happy Day Class-Still I Rise (OHDC-SIR) is a one-time, 4-hour class focused on awareness of depression and healthy self-management strategies ( a workbook is created with the class content). The class is offered in non clinical setting, but will be delivered in a classroom setting at the University. The class will be taught by the PI Dr. Ward, who is an associate professor and licensed psychologist, and Dr. Ward's research program manager, Lucretia Sullivan-Wade.
Intervention Type
Behavioral
Intervention Name(s)
Oh Happy Day Class - Still I Rise
Intervention Description
one-time, 4-hour class focused on awareness of depression and healthy self-management strategies
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PhQ-9)
Description
Patient Health Questionnaire (PHQ-9 is a depression measure. PHQ-9 is a self-administered (5 minutes completion time) depression scale, which scores each of the 9 DSM-IV (Diagnostic and Statistical Manual-IV) criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores are summed, and scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African American male or female Age 25 and older Residence in the state of Wisconsin With or without depression Exclusion Criteria: Self-report of a psychotic disorder such as schizophrenia bipolar disorder Cognitive disorder such as dementia Presently experiencing suicidal ideations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earlise Ward, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities

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