DepressionNCT03940157
Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities
A study testing Oh Happy Day Class - Still I Rise in people with Depression and Awareness, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Awareness, Self-management
- What is being tested?
- Oh Happy Day Class - Still I Rise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American male or female
- Age 25 and older
- Residence in the state of Wisconsin
- With or without depression
Who cannot join
- Self-report of a psychotic disorder such as
- schizophrenia
- bipolar disorder
- Cognitive disorder such as dementia
- Presently experiencing suicidal ideations.
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aims/Study Objectives:
- 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.
- 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.
- 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)
- 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.
Read the 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.
- Conditions
- Depression, Awareness, Self-management
- Being tested
- Oh Happy Day Class - Still I Rise
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oh Happy Day Class - Still I RiseBehavioural
one-time, 4-hour class focused on awareness of depression and healthy self-management strategies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Oh Happy Day Class - Still I Rise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jul 2019
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be exposed to the intervention
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Urban League of Greater Madison, African American Council of Churches Madison, Second Baptist Church, YWCA of Madison
- Responsible party
- Sponsor
- Investigators
- Earlise Ward, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940157
- Sponsor's protocol ID
- 2019-0129
- Other IDs
- A545000, NUR/FACULTY AFFAIRS/ADMIN
- Status last verified
- Nov 2022
- First submitted
- 3 May 2019
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faith and Community in Action: Increasing Awareness and Management of Depression in African American Communities
- ClinicalTrials.gov ID
- NCT03940157
- Acronym / sponsor ID
- 2019-0129
- Conditions
- Depression, Awareness, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Urban League of Greater Madison, African American Council of Churches Madison, Second Baptist Church, YWCA of Madison
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aims/Study Objectives:
- 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.
- 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.
- 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)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be exposed to the intervention
| Arm | Type | Receives |
|---|---|---|
| Oh Happy Day Class - Still I Rise | Experimental | Behavioral: Oh Happy Day Class - Still I RiseThe 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American male or female
- Age 25 and older
- Residence in the state of Wisconsin
- With or without depression
Key exclusion criteria (5 listed)
- Self-report of a psychotic disorder such as
- Cognitive disorder such as dementia
- Presently experiencing suicidal ideations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oh Happy Day Class - Still I Riseone-time, 4-hour class focused on awareness of depression and healthy self-management strategies | Behavioural | Oh Happy Day Class - Still I Rise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earlise Ward, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oh Happy Day Class - Still I Rise in people with Depression and Awareness, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PhQ-9) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.