Cognitive Behavioral and Faith Fellowship to Improve Thy Health

NCT ID: NCT06292637

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects.

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 CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

CB-FAITH treatment

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Earlise Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Second Baptist Church

Madison, Wisconsin, United States

Site Status RECRUITING

The Board of Regents of the UW System

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Earlise Ward, PhD

Role: CONTACT

608/263-0745

Facility Contacts

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Earlise Ward, PhD

Role: primary

608/263-0745

Anthony Wade

Role: primary

608-278-1430

Earlise Ward, PhD

Role: primary

Other Identifiers

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1R01HS029477-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

A545000

Identifier Type: OTHER

Identifier Source: secondary_id

NUR/FACULTY AFFAIRS/ADMIN

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 9/5/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1484

Identifier Type: -

Identifier Source: org_study_id

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