Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - A Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Patient Health Questionnaire
研究概览
简要总结
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.
详细描述
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Patient Health Questionnaire
时间窗: 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.
Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)
时间窗: 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.
次要结局
- Multidimensional Measure of Religious Involvement (MMRI) score(baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months)
- Client Satisfaction Inventory (CSI) score(approximately Week 13-16 (End of CB-FAITH classes))