NCT03940157

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

December 5, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

May 3, 2019

Last Update Submit

November 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Oh Happy Day Class - Still I Rise

EXPERIMENTAL

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

Interventions

one-time, 4-hour class focused on awareness of depression and healthy self-management strategies

Oh Happy Day Class - Still I Rise

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Self-report of a psychotic disorder such as
  • schizophrenia
  • bipolar disorder
  • Cognitive disorder such as dementia
  • Presently experiencing suicidal ideations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Earlise Ward, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will be exposed to the intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 7, 2019

Study Start

July 1, 2019

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

December 5, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations