认知行为和信仰团契改善您的健康 (CB-FAITH)
认知行为和信仰改善健康奖学金 (CB-FAITH) - 可行性和可接受性研究
Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated.
研究概览
详细说明
The randomized stepped wedge design (R-SWD) is a type of cluster randomized controlled trial in which the unit of randomization is a cluster (e.g., church groups with a group of 10 participants), not individual participants. At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) treatment, with all clusters eventually crossing over to receive the treatment.
Primary Aim 1: Examine efficacy of CB-FAITH in reducing symptoms of depression.
Secondary Aim 1: Examine moderating effects of religiosity on treatment effectiveness.
Secondary Aim 2: Evaluate satisfaction with CB-FAITH delivered in church settings.
Impact: CB-FAITH is poised to be the first evidence-based faith-based depression intervention designed for African American adults with depression. This community-prioritized research and transformative intervention has potential to reduce depression symptoms, reduce mental health disparities and advance health equity. Given the impact of COVID-19 pandemic, CB-FAITH is critically needed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53711-3800
- Second Baptist Church
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Madison、Wisconsin、美国、53715-1218
- The Board of Regents of the UW System
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Madison、Wisconsin、美国、53515
- University of Wisconsin - Madison
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- self-identify as an African American man or woman
- are ages 18 and older
- have symptoms of major depressive disorder, as evidenced by score of 10 and higher from the Patient Health Questionnaire-9 (PHQ-9).
Exclusion Criteria:
- major psychotic illnesses, such as schizophrenia;
- current participation in psychotherapy
- current suicidal ideations (trained staff will conduct a suicide risk assessment and facilitate referral for appropriate care).
- Medication stabilization. Eligible participants who report recent changes to their psychiatric medications (i.e., initiation of a new medication, change in dose or type of medication) will delay their study enrollment for a stabilization period of 4 weeks. Baseline data collection will be re-administered
- alcohol or drug dependence - those with alcohol or other drug dependence who have been clean and sober for 3 months will not be excluded
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制
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实验性的:CB-FAITH 治疗
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CB-FAITH is a behavioral depression intervention set inside a cognitive behavioral framework, and Afrocentric paradigm and informed by faith-based principles, designed to treat major depressive disorder among African American adults. The 13-treatment modules focus on increasing knowledge of depression and healthy coping behaviors. It is designed to be co-delivered by licensed mental health clinicians and pastors at churches. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Health Questionnaire
大体时间:baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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Patient Health Questionnaire-9 (PHQ-9) is a self-administered depression scale (5 minute completion time), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Categories of depression symptoms are defined as none (score 0-4), mild (score 5-9), moderate (score 10-14), moderately severe (score 15-19), and severe (score ≥20). In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. |
baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)
大体时间:baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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The 16-item Quick Inventory of Depressive Symptomatology (QIDS) assesses depressive symptom severity and symptom change. Investigators will use the clinician rated QIDS-CR. Scores range from 0-27 and higher scores suggest higher severity of depression. |
baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Multidimensional Measure of Religious Involvement (MMRI) score
大体时间:baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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Religiosity will be measured with the Multidimensional Measure of Religious Involvement (MMRI), a three-dimensional measure of religious involvement, consisting of organizational (frequency of service attendance), non-organizational (use of and frequency of nonorganized activities, such as watching religious programs on TV), and subjective religiosity (self-rated level of religiosity, such as significance of prayer and orientation toward God). It consists of 12 items and is self administered (5-10-minute completion time). Using Likert-scale responses, ranging from: 1 = very religious, 2 = fairly religious, 3 = not too religious, and 4 = not religious at all. |
baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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Client Satisfaction Inventory (CSI) score
大体时间:approximately Week 13-16 (End of CB-FAITH classes)
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Client Satisfaction Inventory (CSI), an 8-item measure of satisfaction with counseling; total scores range from 8 to 32, with the higher number indicating greater satisfaction. The CSI will be self-administered. |
approximately Week 13-16 (End of CB-FAITH classes)
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合作者和调查者
调查人员
- 首席研究员:Earlise Ward, PhD、University of Wisconsin, Madison
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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