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认知行为和信仰团契改善您的健康 (CB-FAITH)

2026年10月21日 更新者:University of Wisconsin, Madison

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

介入性

注册 (实际的)

34

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Wisconsin
      • Madison、Wisconsin、美国、53711-3800
        • Second Baptist Church
      • Madison、Wisconsin、美国、53715-1218
        • The Board of Regents of the UW System
      • Madison、Wisconsin、美国、53515
        • University of Wisconsin - Madison

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
无干预:控制
实验性的:CB-FAITH 治疗

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

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
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

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
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

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
Client Satisfaction Inventory (CSI) score
大体时间:approximately Week 13-16 (End of CB-FAITH classes)

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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Earlise Ward, PhD、University of Wisconsin, Madison

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月8日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2024年2月27日

首先提交符合 QC 标准的

2024年2月27日

首次发布 (实际的)

2024年3月5日

研究记录更新

最后更新发布 (实际的)

2026年10月26日

上次提交的符合 QC 标准的更新

2026年10月21日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2020-1484
  • A545000 (其他标识符:UW Madison)
  • NUR/FACULTY AFFAIRS/ADMIN (其他标识符:UW Madison)
  • 1R01HS029477-01 (美国 AHRQ 拨款/合同)
  • Protocol Version 9/5/2025 (其他标识符:UW Madison)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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