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临床试验/NCT01342536
NCT01342536已完成3 期

A Culturally Adapted Depression Intervention for African American Adults

University of Wisconsin, Madison4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年12月14日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
160
试验地点
4
主要终点
Center for Epidemiologic Studies Depression Scale (CES-D)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

lifestyle counseling (OHDC)

Experimental

Oh Happy Day Class (OHDC) is a culturally-specific, 12-week cognitive behavioral group counseling intervention designed for African American adults experiencing depression

干预措施: Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC) (Behavioral)

lifestyle counseling (CWD)

Active Comparator

Coping with Depression Course (CWD) is a 8-week cognitive behavioral group counseling depression intervention

干预措施: Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC) (Behavioral)

结局指标

主要结局

Center for Epidemiologic Studies Depression Scale (CES-D)

时间窗: up to 4 years

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.

次要结局

  • Quick Inventory of Depressive Symptomatology (QIDS)(up to 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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