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Recruiting NCT06292637

Cognitive Behavioral and Faith Fellowship to Improve Thy Health

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH).
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Patient Health Questionnaire [Time frame: 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) [Time frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months]
Secondary outcome measures (2)
  • Multidimensional Measure of Religious Involvement (MMRI) score [Time frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months]
  • Client Satisfaction Inventory (CSI) score [Time frame: approximately Week 13-16 (End of CB-FAITH classes)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Wisconsin - Madison — Madison
  • Second Baptist Church — Madison
  • The Board of Regents of the UW System — Madison

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗