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NCT01342536 · ClinicalTrials.gov registry record · Phase 3
African American Depression Intervention Trial (AADI)
A Phase 3 study of Major Depressive Disorder, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT01342536: Completed Phase 3 study of Major Depressive Disorder, sponsored by University of Wisconsin, Madison.
NCT01342536 is a Phase 3 study of Major Depressive Disorder that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 160 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342536, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study Summary
Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-, 6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework completion, class-participation level; Client Satisfaction Inventory; and Cornell Service Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months post-intervention. The investigators hypothesize the OHDC will result in greater reduction in depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures: Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms. Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental and physical health status and reducing self-reports of perceived disability. The investigators hypothesize the OHDC compared to the CWD will result in greater self-report of: 3a. improved mental and physical health status, and 3b. reduced self-report of disability at the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule. Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more effective than the CWD. If our hypotheses are proven, the OHDC will be the first evidence-based culturally adapted depression intervention designed specifically for African American men and women between the ages of 30-60.
Primary Outcome
Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a 20-item self-report inventory developed by NIMH to assess the frequency and severity of depression symptoms in the past week. Respondents indicate how often each symptom was experienced during the past week on a four-point scale from "Rarely or none of the time (0)", "Some or a little of the time (1)", "Occasionally or a moderate amount of the time (2)", or "Most or all of the time (3)". Item scores are summed for an
Conditions Studied
Interventions
- BEHAVIORAL Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)
Study Locations (2)
Wisconsin
- Mental Health Center of Dane County - Madison
- Milwaukee Health Services, INC - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-12-14 |
| Est. Completion | 2018-06 |
| Phase | Phase 3 |
What the finished NCT01342536 record still lists
NCT01342536 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC) is the first listed.
NCT01342536 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01342536 about?
NCT01342536 is a clinical study titled "African American Depression Intervention Trial (AADI)". Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in greater increases in: 1a. r...
What is the current status of trial NCT01342536?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2011-12-14. Estimated completion is 2018-06.
What conditions does trial NCT01342536 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01342536?
The interventions under investigation include: Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01342536?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01342536 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01342536's enrollment target sits among peer trials
160 95th of 282 higher than 188 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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