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

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ClinicalTrials.gov Identifier: NCT03940157
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Urban League of Greater Madison
African American Council of Churches Madison
Second Baptist Church
YWCA of Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Depression Awareness Self-management Behavioral: Oh Happy Day Class - Still I Rise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will be exposed to the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oh Happy Day Class - Still I Rise
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.
Behavioral: Oh Happy Day Class - Still I Rise
one-time, 4-hour class focused on awareness of depression and healthy self-management strategies




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PhQ-9) [ Time Frame: 4 months ]
    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.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03940157


Contacts
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Contact: Earlise Ward, PhD 608-263-0745 ecward@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53706
Contact: Earlise Ward, PhD    608-263-0745    ecward@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Urban League of Greater Madison
African American Council of Churches Madison
Second Baptist Church
YWCA of Madison
Investigators
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Principal Investigator: Earlise Ward, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03940157     History of Changes
Other Study ID Numbers: 2019-0129
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders