Cognitive Behavioral and Faith Fellowship to Improve Thy Health

Официальное название

Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - A Feasibility and Acceptability Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)
  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.

Первичные конечные точки

• Patient Health Questionnaire [Срок оценки: 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) [Срок оценки: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months]

Вторичные конечные точки (2)

• Multidimensional Measure of Religious Involvement (MMRI) score [Срок оценки: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months]
• Client Satisfaction Inventory (CSI) score [Срок оценки: approximately Week 13-16 (End of CB-FAITH classes)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Wisconsin - Madison — Madison
• Second Baptist Church — Madison
• The Board of Regents of the UW System — Madison

Идентификаторы

NCT: NCT06292637 · 2020-1484 · 1R01HS029477-01 · A545000 · NUR/FACULTY AFFAIRS/ADMIN · Protocol Version 9/5/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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