Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH)

University of Wisconsin (UW)

Status

Enrolling

Conditions

Depression

Treatments

Behavioral: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06292637

Protocol Version 9/5/2025 (Other Identifier)

2020-1484

A545000 (Other Identifier)

1R01HS029477-01 (U.S. AHRQ Grant/Contract)

NUR/FACULTY AFFAIRS/ADMIN (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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