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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03940157
Other study ID # 2019-0129
Secondary ID A545000NUR/FACUL
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date October 10, 2020

Study information

Verified date November 2022
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date October 10, 2020
Est. primary completion date October 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (5)

Lead Sponsor Collaborator
University of Wisconsin, Madison African American Council of Churches Madison, Second Baptist Church, Urban League of Greater Madison, YWCA of Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 months
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