African American Depression Intervention Trial (AADI)

Major Depressive Disorder Clinical Trial

— AADI  

Official title:

A Culturally Adapted Depression Intervention for African American Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342536
• Other study ID #: 2011-0109, 2011-0234
• Secondary ID: R01MD005905-01A1
• Status: Completed
• Phase: Phase 3
• Start date: December 14, 2011
• Est. completion date: June 2018

Study information

• Verified date: May 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)
The OHDC is a culturally adapted, cognitive behavioral group counseling intervention. The OHDC is theoretically grounded in social learning theory and an Afrocentric paradigm (Nguzo Saba). It uses a social support group and psychoeducation format so participants learn skills to help them in coping and reducing symptoms of depression. The OHDC is offered over 13 weeks with 2-hour sessions in a clinical setting. The CWD, an evidence-based cognitive behavioral depression intervention. The CWD is offered over 8 weeks with 2-hour sessions in a clinical. Arms: lifestyle counseling (OHDC), lifestyle counseling (CWD)

Locations

Country	Name	City	State
United States	Mental Health Center of Dane County	Madison	Wisconsin
United States	Milwaukee Health Services, INC	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

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