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African American Depression Intervention Trial (AADI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2011 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01342536
First received: April 25, 2011
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Culturally Adapted Depression Intervention for African American Adults

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 190
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lifestyle counseling (OHDC)
Oh Happy Day Class (OHDC) is a culturally-specific, 12-week cognitive behavioral group counseling intervention designed for African American adults experiencing depression
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)

Active Comparator: lifestyle counseling (CWD)
Coping with Depression Course (CWD) is a 8-week cognitive behavioral group counseling depression 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)


  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342536

Contacts
Contact: Earlise C Ward, Ph.D. 608-263-0745 ecward@wisc.edu

Locations
United States, Wisconsin
Mental Health Center of Dane County Not yet recruiting
Madison, Wisconsin, United States, 53703
Contact: Earlise C Ward, Ph.D.    608-263-0745    ecward@wisc.edu   
Principal Investigator: Earlise C Ward, Ph.D.         
Milwaukee Health Services, INC Not yet recruiting
Milwaukee, Wisconsin, United States, 53216
Contact: Yvone Bell-Goodin, Ph.D    414-760-3924    ybell_gooden@mhsi.org   
Sub-Investigator: Yvone Bell-Goodin, Ph.D.         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Earlise C Ward, Ph.D. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Earlise Ward, Ph.D., University of Wisconsin-Madison
ClinicalTrials.gov Identifier: NCT01342536     History of Changes
Other Study ID Numbers: 2011-0109, R01MD005905-01A1
Study First Received: April 25, 2011
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014