Major Depressive Disorder Clinical Trial
— AADIOfficial title:
A Culturally Adapted Depression Intervention for African American Adults
Verified date | May 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Inclusion criteria. Self-identified African-American men and women, between the ages of 30 to 60, with symptoms of depression as evidenced by data from the Composite International Diagnostic Interview 2.1 (CIDI). Although age of inclusion is broad, our pilot studies have shown positive outcomes with mixed aged groups Exclusion Criteria: - Exclusion criteria. Individuals will be excluded from the study if they have: (1) self-reported alcohol or other drug abuse/dependence, (2) major psychotic illnesses, such as schizophrenia as evidenced by results of the CIDI, (3) self-reported changes in antidepressants (dosage or type) less than 6 weeks prior to participating in the study, (4) self-report of current psychotherapy treatment, or (5) self-report of current suicidal ideations (our psychiatrist will conduct additional suicide risk assessment and facilitate referral for appropriate care. |
Country | Name | City | State |
---|---|---|---|
United States | Mental Health Center of Dane County | Madison | Wisconsin |
United States | Milwaukee Health Services, INC | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Center for Epidemiologic Studies Depression Scale (CES-D) | 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 analyses, with a possible range 0-60. A standard cutoff score of 16 indicates depressive symptoms. | up to 4 years | |
Secondary | Quick Inventory of Depressive Symptomatology (QIDS) | The 16-item Quick Inventory of Depressive Symptomatology (QIDS) using DSM-IV criteria assesses depressive symptom severity and symptom change. The QIDS has a clinician-rated and self-report format. Studies show high internal consistency for the QIDS-CR (0.85) and QIDS-SR(0.86). Scores range from 0-27 and higher scores suggest higher severity. The QIDS also has high concurrent validity with the SF-12. | up to 4 years |
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